Identity
- Trade Name
- Hu-Friedy FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- SporeCheck In-Office Spore Test, 100 FDA UDI
- Model / Reference
- IMS-1373H FDA UDI
- Description
- SporeCheck In-Office Spore Test, 100 FDA UDI
Identifiers
- Catalog Number
- IMS-1373H FDA UDI
- Primary DI / UDI-DI
- 10889950002664 FDA UDI
- 510(k) Number
- K022706 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
Hu-Friedy by Hu-Friedy Mfg Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022706 also covers:
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 f4b32208-849b-4e3a-b071-4a0a2ed8bf01 37 fields · synced May 31, 2026