Identity
- Trade Name
- restor3d Disposable Trial Kit FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Device Name
- Cotton Kit FDA UDI
- Model / Reference
- 4100-0101 FDA UDI
- Description
- Cotton Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097508702 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
restor3d Disposable Trial Kit by Restor3D — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Restor3D
Sources (1)
- FDA UDI 5d55d5f1-298c-47dc-8171-495b0e41d99e 34 fields · synced May 30, 2026