AccessGUDID - DEVICE: Westcott Scissors Straight Sharp Tip (05060745556793)

GUDID

Device Identifier (DI) Information

Brand Name: Westcott Scissors Straight Sharp Tip
Version or Model: 20-4015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BLINK MEDICAL LIMITED

Primary DI Number: 05060745556793
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 738288096 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66657	Conjunctival scissors, single-use	A 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 and/or drapes, however, it is neither intended for intraocular surgery nor for other extraocular surgeries. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	Scissors, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 516b4e54-25d0-4612-af80-121d96e029e2
Public Version Date: December 19, 2023
Public Version Number: 3
DI Record Publish Date: September 18, 2023