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RoboMarker-Refurbished

FDA UDIEUDAMED

Class I (US FDA UDI)

by Surgilum, LLC

Identity

Trade Name
RoboMarker-Refurbished FDA UDI
Generic Name
Corneal marker handpiece FDA UDI
Device Name
Refurbished corneal marker handle for use with TPS and IRT series marking tips. FDA UDI
Model / Reference
RMS101-R FDA UDI
Description
Refurbished corneal marker handle for use with TPS and IRT series marking tips. FDA UDI

Identifiers

Catalog Number
RMS101R FDA UDI
Primary DI / UDI-DI
B836RMS101R0 FDA UDI
FDA Product Code
HMR FDA UDI
GMDN Term
Corneal marker handpiece FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4570 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Corneal marker handpiece

RoboMarker-Refurbished by Surgilum, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Corneal marker handpiece.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgilum, LLC

Sources (2)

  • FDA UDI 172ee655-df0b-49a9-9ae3-7b6f7dd8f7c5 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026