AccessGUDID - DEVICE: BR Surgical, LLC (00840183528416)

GUDID

Device Identifier (DI) Information

Brand Name: BR Surgical, LLC
Version or Model: BR980-9101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR980-9101
Company Name: BR Surgical, LLC

Primary DI Number: 00840183528416
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134781207 *Terms of Use

Device Description: Minor Balloon Sinus Kit, (5) per box: 4-ply 17" x 19" Towel/Drape, 10cc Control Syringe, Neuro Sponges 1/2" x 3" (10 Patties/Card), 2oz Medicine Cups (3 per pack), 25ga x 3 1/2" Spinal Needle, Half Shallow Tray, 24" x 24" Wrap, Sterilization Pouch

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44069	ENT surgical procedure kit, non-medicated, single-use	A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGR	Ear, Nose, And Throat Surgical Tray

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e5ba72c-0049-4dd5-9dc6-2183394cd1f7
Public Version Date: November 07, 2024
Public Version Number: 1
DI Record Publish Date: October 30, 2024