AccessGUDID - DEVICE: N.A. (J011164000000)

GUDID

Device Identifier (DI) Information

Brand Name: N.A.
Version or Model: 164-000-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011164000000
Issuing Agency: HIBCC
Commercial Distribution End Date: September 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: LinguSil transfer matrix for indirect bonding, Polyvinylsiloxane) / For further information please visit our online-shop on our website www.dentaurum.de

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:	Yes
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?
18083	Bite registration rim	A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. Bite rims can be individually made or adjusted to one patient from preformed devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWL	PROSTHESIS, LARYNGEAL (TAUB)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913537	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage: 18 - 25 °C / 64.4 - 77 °F

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61576f18-aea1-4983-b53d-6a10152bee2d
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: September 15, 2016