AccessGUDID - DEVICE: NOBIL METAL SPA (18056039210230)

GUDID

Device Identifier (DI) Information

Brand Name: NOBIL METAL SPA
Version or Model: LV CLI ATTACHMENTS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CL-694-4IN
Company Name: NOBIL METAL SPA

Primary DI Number: 18056039210230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436857494 *Terms of Use

Device Description: LV CLI RIDER IN LAT. + SM

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):	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?
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHO	Bar, Preformed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f92a68e-6507-4556-b679-4967dae62824
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
28056039210237	2	18056039210230	In Commercial Distribution	box
38056039210234	20	18056039210230	In Commercial Distribution	box
48056039210231	50	18056039210230	In Commercial Distribution	box