AccessGUDID - DEVICE: NOBIL METAL SPA (18056039210247)

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-694-3IN
Company Name: NOBIL METAL SPA

Primary DI Number: 18056039210247
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 OCCL. + 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: fb5535b1-24c1-4a72-a1ec-d67c8f529f7a
Public Version Date: September 24, 2020
Public Version Number: 1
DI Record Publish Date: September 16, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
28056039210244	2	18056039210247	In Commercial Distribution	box
38056039210241	20	18056039210247	In Commercial Distribution	box
48056039210248	50	18056039210247	In Commercial Distribution	box