Identity
- Trade Name
- Merocel FDA UDI
- Generic Name
- Surgical power tool system control unit, pneumatic FDA UDI
- Device Name
- SPONGE 300503 MEROCEL 100PK 1.3 X 2.5CM FDA UDI
- Model / Reference
- 300503 FDA UDI
- Description
- SPONGE 300503 MEROCEL 100PK 1.3 X 2.5CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20643169673247 FDA UDI
- FDA Product Code
- HBA FDA UDI
- GMDN Term
- Surgical power tool system control unit, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 13.0 Millimeter FDA UDILength — 25.0 Millimeter FDA UDI
Merocel by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 5b0de662-62e5-423f-80fd-c5da4d4cbd61 36 fields · synced May 30, 2026