Sage Products, Inc.
Sage Products, Inc. holds FDA 510(k) medical device clearances, first cleared 1978, most recent 1998, with 2 FDA device recalls on record.
Top product codes for Sage Products, Inc.
FDA recalls by Sage Products, Inc.
- Z-0356-2024 — stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Z-2139-2019 — Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sage Products, Inc.
- K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
- K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
- K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER
- K972279 — SHARPS SHUTTLE
- K970135 — NITRILE GLOVES
- K972302 — POCKET COUNT OR SAFETCOUNT
- K964168 — PROCEDURE SPECIFIC KITS
- K963986 — STP SYSTEM PVA WITH ZINC
- K964026 — STP SYSTEM - SAF
- K964027 — STP SYSTEM-PVA WITH MERCURY
- K962168 — MUCUS SPECIMEN TRAP
- K943658 — CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
- K943659 — ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
- K943660 — PHLEBOTOMY SHARPS DISPOSAL CONTAINERS
- K941991 — IN-ROOM AND SHARPSTAR
- K933370 — STOOL TRANSPORT/PROCESSOR
- K901806 — SUCTION ORA-SWAB(R) BRUSH KIT
- K894064 — STERILE HAND COVER
- K874888 — ISOLATION GOWN
- K873569 — BLOOD NEEDLE HOLDER
- K823413 — MOUTH CARE KIT W/TOOTHBRUSH
- K823411 — PEDIATRIC URINE COLLECTOR
- K823412 — ARM BOARD W/I.V COVERING
- K820246 — PREFILLED SPECIMEN CONTAINER
- K813408 — SAGE 2200 STERILE SPECIMEN CONTAINER
- K800946 — URINARY CATHETER SAMPLING KIT
- K800947 — MIDSTREAM COLLECTION KIT
- K800397 — ELLIK BLADDER EVACUATOR
- K800309 — SPECIMEN COLLECTION PAN
- K790291 — OPERATING ROOM SPECIMEN CONTAINER
- K781557 — 24-HOUR URINE COLLECTION COOLING WRAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.