AccessGUDID - DEVICE: TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants (00083208920004)

GUDID

Device Identifier (DI) Information

Brand Name: TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants
Version or Model: 2.0 RH Integrity Abutment Screw
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PITI-2.0 AS
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208920004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants

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?
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Millimeter
Device Size Text, specify: Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants

Device Record Status

Public Device Record Key: 39204ada-3fb5-4ec3-9c46-e55ca2eaa3d3
Public Version Date: January 18, 2023
Public Version Number: 6
DI Record Publish Date: August 24, 2018