Identity
- Trade Name
- Sharps FDA UDI
- Generic Name
- Sharps container FDA UDI
- Device Name
- 3-Gallon Sharps Container - Standard FDA UDI
- Model / Reference
- 100010 FDA UDI
- Description
- 3-Gallon Sharps Container - Standard FDA UDI
Identifiers
- Catalog Number
- 100010 FDA UDI
- Primary DI / UDI-DI
- 00634188001865 FDA UDI
- 510(k) Number
- K083129 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sharps container
Sharps by Sharps Compliance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sharps container.
- SharpSafety — Cardinalhealth · Class II
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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
Cleared under the same submission
K083129 also covers:
- IgCares — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Sharps — Sharps Compliance, Inc.
- Takeda — Sharps Compliance, Inc.
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
- Sharps Compliance, Inc.
Sources (1)
- FDA UDI fdc0977b-5ca7-4291-b2a3-27d26575d1b3 35 fields · synced May 30, 2026