FDA.report

Marker Double Ended 3.5mm-4mm

Primary DI
05060480407978
Brand
Marker Double Ended 3.5mm-4mm
Company
BLINK MEDICAL LIMITED
Model
90-1015
Published
2022-06-30
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
HMQMarker, Sclera

Product Code Classifications

CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480402478PackageGS110In Commercial Distribution
05060480407978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480402478050604804024785060480402478
05060480407978050604804079785060480407978

GMDN Terms

TermDefinition
Scleral marker, single-useA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
738288096
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

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