AccessGUDID - DEVICE: Symmetry Schocket (00887482111505)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Schocket
Version or Model: 60-2010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-2010
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482111505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Symmetry® Depressor, Shocket Scleral, Pocket Clip, Small Thimble, 6 mm Wide Bar, Double-Ended, 5 1/8 in

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:	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?
16465	Orbital depressor, reusable	A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, 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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 6 Millimeter
Length: 5.125 Inch

Device Record Status

Public Device Record Key: acded87e-9897-48e9-a3bc-97531b39dfef
Public Version Date: March 27, 2025
Public Version Number: 3
DI Record Publish Date: August 12, 2024