AccessGUDID - DEVICE: BR Surgical, LLC (00840183519841)

GUDID

Device Identifier (DI) Information

Brand Name: BR Surgical, LLC
Version or Model: BR02-18091
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR02-18091
Company Name: BR Surgical, LLC

Primary DI Number: 00840183519841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134781207 *Terms of Use

Device Description: ZIEGLER Head Mirror, 3 1/2" (90mm), with leather headband

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?
32707	Ophthalmic head reflector	A head-worn ophthalmic device consisting of a circular concave mirror attached to a headband worn by an examiner, designed to reflect light onto the eye of a patient to allow examination of the eye and its associated structures. This is a reusable device.	Active	false
34637	Head reflector	A head-worn device consisting of a circular concave mirror (reflector) attached to a headband designed to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient. The examiner wears the device on his/her head, places the reflector in front of one eye, and views the site through a small hole in the centre of the reflector. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKF	Mirror, Headband, Ophthalmic

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: eb3da22f-5510-4c08-9a7c-4ec815ffd7f9
Public Version Date: April 03, 2023
Public Version Number: 1
DI Record Publish Date: March 24, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-904-642-1366
Email: customerservice@brsurgical.com

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