Identity
- Trade Name
- Opti-Tatt™ Field Borders FDA UDI
- Generic Name
- Skin marking transfer paper FDA UDI
- Device Name
- Opti-Tatt, Field Border, Sheet of 24 FDA UDI
- Model / Reference
- UTRT-4300 FDA UDI
- Description
- Opti-Tatt, Field Border, Sheet of 24 FDA UDI
Identifiers
- Catalog Number
- UTRT-4300 FDA UDI
- Primary DI / UDI-DI
- 00714646001016 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Skin marking transfer paper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4660 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin marking transfer paper
Opti-Tatt™ Field Borders by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin marking transfer paper.
- Skin Marking Grid — Allergan · Class I
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- Sample: Opti-Tatt — Bionix, 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
- Bionix, LLC
Sources (1)
- FDA UDI e434072c-881d-47e3-b537-fa8ff0d28566 36 fields · synced Jun 8, 2026