AccessGUDID - DEVICE: STERLING (00366975069344)

GUDID

Device Identifier (DI) Information

Brand Name: STERLING
Version or Model: 5259-507
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BENCO DENTAL SUPPLY CO.

Primary DI Number: 00366975069344
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 015108087 *Terms of Use

Device Description: STERLING Handpiece 1:5 Increasing Fiber-Optic ERL 95 1:5

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?
12352	Fibreoptic dental light	A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a856e675-b076-406c-8271-b8c876d8c0f2
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024