AccessGUDID - DEVICE: Batrik Corner Pockets (00690521012240)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Corner Pockets
Version or Model: 18-CP07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-CP07
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521012240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Corner Pockets protectors, Orange, Reusable

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?
63494	Instrument tray corner protector, reusable	A device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: Store at ambient temperature and away from direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d8f7a2c-c026-4aaa-8472-a5487e0a68de
Public Version Date: November 06, 2020
Public Version Number: 2
DI Record Publish Date: September 25, 2020