FDA.report

Alexandra Muscle Hook

Primary DI
05060480408142
Brand
Alexandra Muscle Hook
Company
BLINK MEDICAL LIMITED
Model
90-5005
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
HNQHook, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480402645PackageGS110In Commercial Distribution
05060480408142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480402645050604804026455060480402645
05060480408142050604804081425060480408142

GMDN Terms

TermDefinition
Soft-tissue surgical hook, single-useA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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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