AccessGUDID - DEVICE: Endo-Eze AET Contra Angle (00883205021076)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Eze AET Contra Angle
Version or Model: 3219-
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3219-
Company Name: ULTRADENT PRODUCTS, INC.

Primary DI Number: 00883205021076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013369913 *Terms of Use

Device Description: ENDO CONTRA ANGLE LOANER

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?
34699	Dental laboratory drilling system motor	A mains electricity (AC-powered) engine (motor) used in a dental laboratory in conjunction with a flexible drive system (e.g., a Bowden cable) to provide the rotational power for a dental laboratory handpiece. It is typically combined with different speed controllers. 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 [?]
K992380	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: f26abc78-d737-4747-805e-0c128675cd42
Public Version Date: October 05, 2018
Public Version Number: 1
DI Record Publish Date: September 04, 2018