AccessGUDID - DEVICE: INTRA Surgery Handpiece 3630 N (EKAV053456700)

GUDID

Device Identifier (DI) Information

Brand Name: INTRA Surgery Handpiece 3630 N
Version or Model: 0.534.5670
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3630 N
Company Name: KaVo Dental GmbH

Primary DI Number: EKAV053456700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333710619 *Terms of Use

Device Description: This is a medical device.

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?
66227	Dental surgical power tool motor, electric	A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy 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

FDA Product Code

[?]

Product Code	Product Code Name
EFB	HANDPIECE, AIR-POWERED, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073478	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
Handling Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce007f49-4374-41d6-9c51-7d2c46d508ab
Public Version Date: August 10, 2022
Public Version Number: 6
DI Record Publish Date: September 26, 2016