AccessGUDID - DEVICE: Batrik First Check Scope Bag 24" (00690521016095)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik First Check Scope Bag 24"
Version or Model: 17-HAP24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-HAP24
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521016095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Transport Bags fo Endoscope & Medical Instruments (Clean Instruments Bags), 24"x 22"

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?
64018	Instrument hygienic-transportation bag	A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use 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: 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: cdb1ece0-8a31-4f36-9c4c-2c62224197b8
Public Version Date: December 14, 2021
Public Version Number: 1
DI Record Publish Date: December 06, 2021