Identity
- Trade Name
- Accupach VI FDA UDI
- Generic Name
- Ultrasound pachymeter FDA UDI
- Model / Reference
- 24-6200 FDA UDI
Identifiers
- Catalog Number
- 24-6200 FDA UDI
- Primary DI / UDI-DI
- 00897826002055 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ultrasound pachymeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasound pachymeter
Accupach VI by Accutome, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound pachymeter.
- Pachmate 2 Calbox — DGH Technology, Inc. · Class II
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- Pachmate Calbox — DGH Technology, Inc. · Class II
- Pachymetry probe — Nidek, Inc. · Class II
- Gilras — U.S. OPHTHALMIC, L.L.C. · Class II
- Single Measurement Calbox — DGH Technology, Inc. · Class II
- Pachette 4 Calbox — DGH Technology, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Accutome, Inc.
Sources (1)
- FDA UDI c2612c56-5417-43a8-a9f4-495096085ad5 33 fields · synced May 30, 2026