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Rumex

FDA UDI

Class I (US FDA UDI)

by Rumex International Co.

Identity

Trade Name
Rumex FDA UDI
Generic Name
LASEK alcohol well, reusable FDA UDI
Device Name
Corneal Trephine Blades, 10.00 mm FDA UDI
Model / Reference
16-0321 FDA UDI
Description
Corneal Trephine Blades, 10.00 mm FDA UDI

Identifiers

Catalog Number
16-0321 FDA UDI
Primary DI / UDI-DI
00840159910054 FDA UDI
FDA Product Code
HRH FDA UDI
GMDN Term
LASEK alcohol well, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: LASEK alcohol well, reusable

Rumex by Rumex International Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as LASEK alcohol well, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rumex International Co.

Sources (1)

  • FDA UDI 50ac2c5b-1568-4078-b7cb-331ec7c41c08 34 fields · synced Jun 9, 2026