Identity
- Trade Name
- OPTICS ONE FDA UDI
- Generic Name
- Pressure bandage, non-latex, sterile FDA UDI
- Device Name
- Esmark Bandage 4in x 12ft FDA UDI
- Model / Reference
- MTI-412 FDA UDI
- Description
- Esmark Bandage 4in x 12ft FDA UDI
Identifiers
- Catalog Number
- MTI-412 FDA UDI
- Primary DI / UDI-DI
- 00815384023312 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Pressure bandage, non-latex, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Pressure bandage, non-latex, sterile
Optics One by Medical Technique, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medical Technique, Inc.
Sources (1)
- FDA UDI e0a99008-4ea7-45f0-a398-1f8dd9fd9902 35 fields · synced Jun 8, 2026