AccessGUDID - DEVICE: Batrik Black Padlock Security Tags (00690521005457)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Black Padlock Security Tags
Version or Model: 15-790
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-790
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521005457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Padlock Security Tags, Double Locking Hooks, Regular, Black

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:	Yes
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?
63106	Femoral artery compression system, electric	A noninvasive, electrically-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure. It includes a compression disc/block intended to extend (to increase pressure) under power of an electric motor contained within a handle with controls; it is held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It is typically used following coronary angiography/ventriculography and PTCA. 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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 98041671-4e0b-41de-ac57-f0586f7fbd3f
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: December 16, 2021