AccessGUDID - DEVICE: McPherson-Westcott Conjunctival Scissors (00192896121331)

GUDID

Device Identifier (DI) Information

Brand Name: McPherson-Westcott Conjunctival Scissors
Version or Model: 13-3300Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-3300Q
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896121331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: McPherson-Westcott Conjunctival Scissors Small Curved Blunt Blades Quantum

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
63553	Conjunctival scissors, reusable	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 reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 4 Inch

Device Record Status

Public Device Record Key: 6a6bd35f-2fe1-4a08-acbd-81fa7f6fb245
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025