Identity
- Trade Name
- Spand-Gel FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Spand-Gel Hydrogel Dressing Sheet - Size 6 IN x 9 IN - Sterile FDA UDI
- Model / Reference
- SPHSA6.9 FDA UDI
- Description
- Spand-Gel Hydrogel Dressing Sheet - Size 6 IN x 9 IN - Sterile FDA UDI
Identifiers
- Catalog Number
- SPHSA6.9 FDA UDI
- Primary DI / UDI-DI
- 00027479251115 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
Spand-Gel by Medi-Tech International Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medi-Tech International Corporation
Sources (1)
- FDA UDI 5c3d4887-190f-4caf-837d-2bacdbc33b07 36 fields · synced May 31, 2026