AccessGUDID - DEVICE: Symmetry OPTI-LENGTH® KERRISON (00887482026885)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry OPTI-LENGTH® KERRISON
Version or Model: 67-7276
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 67-7276
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482026885
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: LUMBAR RONGUER, 5MM BITE, 40 DEGREES UP, 10"

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Intervertebral disc rongeur	A surgical instrument designed for introduction between the bodies of vertebrae for the removal of the broad and flattened disc of fibrocartilage through a cutting/biting action. It is typically made of high-grade stainless steel and constructed as a long instrument with one sliding and one stationary rod, each having a sharp-edged, scoop-shaped, jaw at the distal end which is activated through two pivoted handles that, when squeezed together, close the jaws to bite (cut) through tissue. It is designed to withstand the forces which are applied in order to bite over such tough tissue whilst having a thin enough profile to enable entry into this narrow space. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Intervertebral disc rongeur

A surgical instrument designed for introduction between the bodies of vertebrae for the removal of the broad and flattened disc of fibrocartilage through a cutting/biting action. It is typically made of high-grade stainless steel and constructed as a long instrument with one sliding and one stationary rod, each having a sharp-edged, scoop-shaped, jaw at the distal end which is activated through two pivoted handles that, when squeezed together, close the jaws to bite (cut) through tissue. It is designed to withstand the forces which are applied in order to bite over such tough tissue whilst having a thin enough profile to enable entry into this narrow space. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HAE	Rongeur, Manual

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: a5796e64-19df-4f30-af7d-73b63f3fff28
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 08, 2016