AccessGUDID - DEVICE: Cordless high performance LED headlight (04053755180318)

GUDID

Device Identifier (DI) Information

Brand Name: Cordless high performance LED headlight
Version or Model: 10-122-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-122-00
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04053755180318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: "HighLite" with comfortable headband transformer & charger, with mobile

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":	Yes
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?
46808	Head-worn fibreoptic light	A fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.	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: 3427c34c-2388-4a2d-8418-ccb3ffccba2d
Public Version Date: October 04, 2022
Public Version Number: 1
DI Record Publish Date: September 26, 2022