AccessGUDID - DEVICE: Johnson-Promident (00840326407004)

GUDID

Device Identifier (DI) Information

Brand Name: Johnson-Promident
Version or Model: 1-1EL30-ASSY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1-1EL30-ASSY
Company Name: Young Innovations, Inc.

Primary DI Number: 00840326407004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004193103 *Terms of Use

Device Description: E 1:1 SHEATH AND 30K LATCH HEAD

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?
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
EFB	Handpiece, air-powered, 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: 3c649180-e04e-4884-b591-e26bfb583ecc
Public Version Date: December 02, 2022
Public Version Number: 1
DI Record Publish Date: November 24, 2022