FDA.report

Clamp Desmares Entropian Right

Primary DI
05060480408128
Brand
Clamp Desmares Entropian Right
Company
BLINK MEDICAL LIMITED
Model
90-4009
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
HODClamp, Eyelid, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HODClamp, Eyelid, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480402621PackageGS110In Commercial Distribution
05060480408128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480402621050604804026215060480402621
05060480408128050604804081285060480408128

GMDN Terms

TermDefinition
Eyelid clampA hand-held manual surgical instrument designed to atraumatically grasp and hold the eyelid during an ophthalmic surgical intervention, e.g., removal of a cyst or eyelid margin correction and plastic surgery of the eyelid. It is typically metallic and is available in various sizes and designs. This is a reusable 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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