AccessGUDID - DEVICE: Symmetry Surgical (00887482021477)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical
Version or Model: 51-1088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51-1088
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482021477
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: Punch 5.0 Mm/8"

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?
35287	Bone punch, reusable	A hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. This is a reusable device.	Obsolete	false

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: 9e72c90f-5bd5-4c25-9d4b-7200dc060b0c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 27, 2016