AccessGUDID - DEVICE: N/A (00840329811099)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: B78482
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B78482
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: 00840329811099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: VOROTEK "O SCOPE" - SPECFRAME STNDRD KIT-AUDIOL; 3 DIOPTER, 10HR BATT PK, CHRGER: RECOMM FOR INDIV

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):	Yes
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?
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBA	LIGHT, SURGICAL HEADLIGHT

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: e277d381-ddfb-4ab2-b788-a51f56cb6a0a
Public Version Date: September 29, 2022
Public Version Number: 1
DI Record Publish Date: September 21, 2022