Identity
- Trade Name
- IsoMark™ Sample, Pink Ink FDA UDI
- Generic Name
- Tattoo ink, dermal FDA UDI
- Device Name
- IsoMark™ Sample, Pink Ink FDA UDI
- Model / Reference
- SP-23102 FDA UDI
- Description
- IsoMark™ Sample, Pink Ink FDA UDI
Identifiers
- Catalog Number
- 23102 FDA UDI
- Primary DI / UDI-DI
- 00714646000958 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Tattoo ink, dermal 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Tattoo ink, dermal
IsoMark™ Sample, Pink Ink by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tattoo ink, dermal.
- Ink Align — Flow X-Ray Corp. · Class I
- Ink Align — Flow X-Ray Corp. · Class I
- SteriTatt Original Black Cartridge — Flow X-Ray Corp. · Class I
- Ink Align — Flow X-Ray Corp. · Class I
- SteriTatt — Flow X-Ray Corp. · Class I
- Bionix, LLC — Bionix, LLC · Class I
- Bionix, LLC — Bionix, LLC · Class I
- IsoMark™ — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI afd34adb-9662-49b1-98d3-5f5dd06a29e9 35 fields · synced May 30, 2026