AccessGUDID - DEVICE: SABLE - Hygienist Package (00841359060129)

GUDID

Device Identifier (DI) Information

Brand Name: SABLE - Hygienist Package
Version or Model: 1600025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sable Industries Inc

Primary DI Number: 00841359060129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255407272 *Terms of Use

Device Description: Hygienist One Piece 4:1 Screw-In E-Type Package Package Contains: Air Motor (1600110), Contra Angle (1600216)

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:	Yes
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?
66228	Dental surgical power tool motor, pneumatic	A hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.	Active	false
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083101	000

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: 9b78aa9d-0234-4e4b-9748-6f4e63ba8bae
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022