AccessGUDID - DEVICE: Eighteeth (06941877819248)

GUDID

Device Identifier (DI) Information

Brand Name: Eighteeth
Version or Model: Wireless Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5080902
Company Name: Changzhou Sifary Medical Technology Co., Ltd.

Primary DI Number: 06941877819248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560366787 *Terms of Use

Device Description: Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

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?
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: 714f65ac-0faf-48ce-94f1-0973cb638dd9
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025