AccessGUDID - DEVICE: Contra Angle 8:1 Endodontics (ENOU5057NOU0)

GUDID

Device Identifier (DI) Information

Brand Name: Contra Angle 8:1 Endodontics
Version or Model: 5057NOU
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nouvag AG

Primary DI Number: ENOU5057NOU0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480610476 *Terms of Use

Device Description: Contra Angle 8:1 Endodontics

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?
45573	Line-powered dental drilling/sawing system handpiece	A mains electricity (AC-powered), hand-held, dental device with a low-voltage electric motor (e.g., 24 volt) that provides power to a variety of attachable cutting endpieces for: 1) rotational motion (for drill bits, burs, and other rotary devices); and 2) reciprocal/oscillating motion for saw blades, as used in dental procedures to bore/excavate/saw bones, teeth, and tough tissues. It is typically connected via an electrical cord to a dental delivery system or a freestanding independent system. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022505	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: 70871d9f-3273-4e9a-a2f4-2b7a41909ce7
Public Version Date: September 21, 2018
Public Version Number: 1
DI Record Publish Date: August 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41718466600
Email: info@nouvag.com

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