AccessGUDID - DEVICE: Batrik Silicone Pin Mat (00690521011991)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Silicone Pin Mat
Version or Model: 13-2005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-2005
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521011991
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Silicone Pin Mat, Reusable and Autoclave, 13" x 18" / 33cm x 45cm

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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
FSM	Tray, Surgical, Instrument

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
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a9a46a5-3511-4009-93d3-d3fe1898e8e7
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020