AccessGUDID - DEVICE: Batrik Sheet Tape\8.5x11\W-Lavender (00690521003514)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Sheet Tape\8.5x11\W-Lavender
Version or Model: T-850-4-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T-850-4-11
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521003514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Identification Sheet Tape, White/Lavender stripes, contains different size adhesive strips

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?
47285	Auditory brainstem implant system	An assembly of electronic devices intended to restore useful hearing to a deaf patient via electrical stimulation of the brainstem's cochlear nucleus. It typically includes an external speech processor and microphone/headset to transform acoustical signals into an electrical code, which is transmitted from the headset to a surgically implanted receiver-stimulator where it is decoded and delivered to a multichannel electrode array. The array is surgically placed on the cochlear nucleus, which when stimulated results in the signal's transmission to the brain where it is interpreted as sound. An auditory brainstem implant (ABI) is used to treat deafness resulting from auditory nerve tumours.	Active	true

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: 1ef83e10-7531-46de-b5d0-c4574073ad3c
Public Version Date: November 05, 2021
Public Version Number: 1
DI Record Publish Date: October 28, 2021