AccessGUDID - DEVICE: Symmetry Surgical® (00887482112878)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical®
Version or Model: 61-0135
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61-0135
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482112878
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Symmetry® Crimper, Schuknecht Wire, 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?
47510	ENT wire crimper	A hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNQ	Forceps, Wire Closure, Ent, Non-Sterile

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
No Device Sizes

Device Record Status

Public Device Record Key: 358bcde4-f104-413a-8421-b6b85c03c0e3
Public Version Date: January 10, 2025
Public Version Number: 2
DI Record Publish Date: August 20, 2024