Identity
- Trade Name
- Sharps Clean-Up Kit FDA UDI
- Generic Name
- Sharps container FDA UDI
- Device Name
- Contents: Sharps Shaft, Pair of Gloves, Tweezers, BZK Towelette, Biohazard Bag, Twist Tie. FDA UDI
- Model / Reference
- 1267 FDA UDI
- Description
- Contents: Sharps Shaft, Pair of Gloves, Tweezers, BZK Towelette, Biohazard Bag, Twist Tie. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117338128 FDA UDI
- 510(k) Number
- K201523 FDA UDI
- FDA Product Code
- MMK FDA UDI
- GMDN Term
- Sharps container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sharps container
Sharps Clean-Up Kit by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sharps container.
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- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- SharpSafety — Cardinalhealth · Class II
- SharpsTank — REHRIG PACIFIC COMPANY · Class II
- BD Sharps Collector — BECTON DICKINSON AND COMPANY · Class II
- Stericycle Reusable Sharps Container — Stericycle, Inc. · Class II
- Daniels — DANIELS CORPORATION INTERNATIONAL PTY LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 169f5bd5-c58c-46a9-98db-f488f15f4c8d 34 fields · synced May 30, 2026