Identity
- Trade Name
- GPS FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- STERI-POUCHES DEFEND+ 3 1/2'' X 5 1/4'' FDA UDI
- Model / Reference
- 45-1500 FDA UDI
- Description
- STERI-POUCHES DEFEND+ 3 1/2'' X 5 1/4'' FDA UDI
Identifiers
- Primary DI / UDI-DI
- 90817800020120 FDA UDI
- 510(k) Number
- K143637 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sterilization packaging, single-use
Gps by Group Practice Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilization packaging, single-use.
- Dental City — ICP, INC. · Class II
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- VIVIT Supply — Vivit Supply LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Arjo Wiggins Medical, Inc. — Sterimed, Inc. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
Cleared under the same submission
K143637 also covers:
- FOMED — Fomed Industries Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply Inc
- House Brand Dentistry — Frontier Dental Supply 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Group Practice Solutions
Sources (1)
- FDA UDI 8a7e2f1b-fe63-468a-ae70-8cad27cbdc39 34 fields · synced May 30, 2026