AccessGUDID - DEVICE: Brock String (B091151330)

GUDID

Device Identifier (DI) Information

Brand Name: Brock String
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gulden Ophthalmics Inc.

Primary DI Number: B091151330
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002373249 *Terms of Use

Device Description: No description.

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?
63587	Ophthalmic binocular gauge	A noninvasive, hand-held, manual device intended to be used during an eye examination to determine objective and subjective convergence points, examine accommodation, and determine the master eye. Often called a Royal Air Force (RAF) convergence rule or RAF binocular gauge, it consists of a rule (typically 50cm long and multi-sided for taking different measurements) with a sliding test panel (typically multi-sided to allow different tests); it may have a handle at one end and a Y-shaped face rest at the other. Testing includes measuring the near distance at which, e.g., double vision is observed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXR	Fixation, Vision Training, Binocular

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: 82e51028-d71e-4420-8d20-938eacc21419
Public Version Date: July 13, 2023
Public Version Number: 1
DI Record Publish Date: July 05, 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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