Identity
- Trade Name
- MICROKERATOME Disposable Tubing FDA UDI
- Generic Name
- Keratome, line-powered FDA UDI
- Device Name
- Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery. FDA UDI
Identifiers
- Catalog Number
- 5070063 FDA UDI
- Primary DI / UDI-DI
- 04050555000839 FDA UDI
- FDA Product Code
- HNO FDA UDI
- GMDN Term
- Keratome, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4370 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Keratome, line-powered
MICROKERATOME Disposable Tubing by Technolas GmbH Perfect Vision — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Keratome, line-powered.
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
- Technolas GmbH Perfect Vision
Sources (1)
- FDA UDI 65285606-680c-4f1b-a474-acec5b418029 36 fields · synced Jun 8, 2026