AccessGUDID - DEVICE: High-speed Turbine Handpieces for Single Use (06970278690323)

GUDID

Device Identifier (DI) Information

Brand Name: High-speed Turbine Handpieces for Single Use
Version or Model: TBY03-BZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beijing Dongbo Dental Handpiece Co.,Ltd.

Primary DI Number: 06970278690323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544504276 *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:	Yes
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?
40958	Dental power tool system handpiece, pneumatic	A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172543	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 291e5632-fbb3-427e-97ee-d5e55c6f7246
Public Version Date: March 16, 2020
Public Version Number: 1
DI Record Publish Date: March 06, 2020