Identity
- Trade Name
- Hu-Friedy FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- IMS STERILIZATION WRAP 24 x 24 100 SHEET FDA UDI
- Model / Reference
- IMS-1210H FDA UDI
- Description
- IMS STERILIZATION WRAP 24 x 24 100 SHEET FDA UDI
Identifiers
- Catalog Number
- IMS-1210H FDA UDI
- Primary DI / UDI-DI
- 10889950002732 FDA UDI
- 510(k) Number
- K800123 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, single-use
Hu-Friedy by Hu-Friedy Mfg Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sterilization packaging, single-use.
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Cleared under the same submission
K800123 also covers:
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
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
- Hu-Friedy Mfg Co., Llc
Sources (1)
- FDA UDI beebb452-e05f-468f-83ed-85c58ee5c88a 36 fields · synced Jun 8, 2026