Identity
- Trade Name
- BUNION SPLINT LG RT FDA UDI
- Generic Name
- Bunion shield FDA UDI
- Model / Reference
- 08146224 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570021505 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Bunion shield FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
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
Category: Bunion shield
Bunion Splint Lg Rt by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bunion shield.
- Therastep Gel Bunion Cushion Fr/Eng, 1/blister — SILIPOS Holding LLC · Class I
- VIVE — VIVE HEALTH LLC · Class I
- All Gel Bunion Shield, Hallux, 2pc/bag (Miles Kimball #337084) - same part as 11 — SILIPOS Holding LLC · Class I
- All Gel Antibacterial Bunion Shield, Tailors, Small, 1pc/bag — SILIPOS Holding LLC · Class I
- Gel Bunion Guard, Small, 5pc/clamshell — SILIPOS Holding LLC · Class I
- All Gel Antibacterial Bunion Shield, Hallux, Large, 1pc/bag — SILIPOS Holding LLC · Class I
- All Gel Bunion Shield, Tailors, Small, 1pc/bag — SILIPOS Holding LLC · Class I
- All Gel Bunion Shield, Hallux, Large, 1pc/bag — SILIPOS Holding LLC · Class I
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
- Bird & Cronin, Llc
Sources (1)
- FDA UDI e7735a5e-c198-4930-b8d5-7ea98d27ac82 32 fields · synced Jun 1, 2026