Identity
- Trade Name
- Opti-Tatt™ Crosshairs FDA UDI
- Generic Name
- Skin marking transfer paper FDA UDI
- Device Name
- Opti-Tatt, Crosshair, Sheet of 24 FDA UDI
- Model / Reference
- UTRT-4200 FDA UDI
- Description
- Opti-Tatt, Crosshair, Sheet of 24 FDA UDI
Identifiers
- Catalog Number
- UTRT-4200 FDA UDI
- Primary DI / UDI-DI
- 00714646001009 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™ Crosshairs by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Skin marking transfer paper.
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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 55e44289-a9a5-41f8-a286-57701b2331a3 36 fields · synced May 31, 2026