AccessGUDID - DEVICE: Symmetry Surgical® (00887482142134)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical®
Version or Model: 9020-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9020-04
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482142134
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: FlashPak® Mat, Silicone Pin Mat, For 9020-08

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?
63376	Sterilization container mat	A non-sterile soft polymer sheet intended to be placed within a container/tray used for instrument sterilization, to protect and help facilitate complete sterilization of the underside of instruments. It is in the form of a textured sheet, typically with flexible polymer pins designed to reduce instrument/surface contact. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113776	000

Device Exempt from Premarket Submission: No 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: 011acad5-1842-4315-8b45-20b1612ddb3c
Public Version Date: January 30, 2025
Public Version Number: 2
DI Record Publish Date: September 26, 2018