AccessGUDID - DEVICE: BR Surgical, LLC (00840183526481)

GUDID

Device Identifier (DI) Information

Brand Name: BR Surgical, LLC
Version or Model: BR02-50581
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR02-50581
Company Name: BR Surgical, LLC

Primary DI Number: 00840183526481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134781207 *Terms of Use

Device Description: Queen square pattern Hammer, plastic flexible handle with round rubber head and reflex point, 13"

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:	No
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?
11950	Percussion hammer, manual, reusable	A hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWZ	Percussor

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85f87fcd-73b7-4d3c-b5bb-569ebb78c97f
Public Version Date: May 28, 2024
Public Version Number: 1
DI Record Publish Date: May 20, 2024