AccessGUDID - DEVICE: Batrik Bitestrong'/20mm/Adult/Single/STRAP ATTACHED (00690521015081)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Bitestrong'/20mm/Adult/Single/STRAP ATTACHED
Version or Model: B3-SA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B3-SA
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521015081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: BitestrongTM Bite Blocks, with attached strap on one side, 20 mm, Adult, single use

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?
34143	Endoscopic bite block, basic, single-use	A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNK	Endoscopic Bite Block

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: a3caa462-e35e-4610-a7e5-d5adc5a6d587
Public Version Date: November 08, 2021
Public Version Number: 1
DI Record Publish Date: October 29, 2021