FDA.report

Surgilum

Primary DI
B836IRT1010
Brand
Surgilum
Company
SURGILUM, LLC
Model
IRT101
Catalog number
IRT101
Device description
A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device.
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HMRMarker, Ocular

Product Code Classifications

CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B836IRT1012PackageHIBCC25In Commercial Distribution
B836IRT1010PrimaryHIBCC0

GMDN Terms

TermDefinition
Corneal marker handpiece tipA sterile device intended to be fitted to a corneal marker handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is typically a small device preloaded with ink. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
079726409
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B836RMS101R0RoboMarker-RefurbishedRMS101-RRMS101R2022-11-30
B836TPSG2RoboTip G2TPSG2TPSG22022-08-08
B836RMSG2RoboMarker G2RMSG2RMSG22022-08-02
B836TPS1010SurgilumTPS101TPS1012020-10-12
B836RMS1010SurgilumRMS101RMS1012020-10-01

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