FDA.report

Scissors Westcott Straight Blunt

Primary DI
05060480407381
Brand
Scissors Westcott Straight Blunt
Company
BLINK MEDICAL LIMITED
Model
20-4006
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
HNFScissors, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480401884PackageGS110In Commercial Distribution
05060480407381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480401884050604804018845060480401884
05060480407381050604804073815060480407381

GMDN Terms

TermDefinition
Conjunctival scissorsA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (thumb ring-handles or tweezers-like handles). It is typically made of metal and is available in various designs and sizes. It may additionally be used for cutting sutures, however it is not intended for intraocular surgery, nor for other extraocular surgeries. This is a reusable device intended to be sterilized prior to use.

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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