Identity
- Trade Name
- Axiom® Lig-A-Boots® FDA UDI
- Generic Name
- Vascular booties FDA UDI
- Device Name
- Instrument Jaw Covers, White FDA UDI
- Model / Reference
- 300 FDA UDI
- Description
- Instrument Jaw Covers, White FDA UDI
Identifiers
- Primary DI / UDI-DI
- M6653000 FDA UDI
- 510(k) Number
- K820161 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Vascular booties FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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: Vascular booties
Axiom® Lig-A-Boots® by Axiom Medical, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI 9766798c-4e3d-42ee-814c-b138ad29b634 35 fields · synced May 31, 2026