AccessGUDID - DEVICE: DS Implants (07392532261367)

GUDID

Device Identifier (DI) Information

Brand Name: DS Implants
Version or Model: 68012229
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 68012229
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: 07392532261367
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: MultiBase Abutment Head with holder

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?
42354	Transgingival implant	A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, implant, dental, endosseous

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5381a80e-d63f-4b4f-82a8-11d57bf30d66
Public Version Date: August 30, 2023
Public Version Number: 3
DI Record Publish Date: April 11, 2022