AccessGUDID - DEVICE: RP Prosthetic Screw Titanium (00841549110542)

GUDID

Device Identifier (DI) Information

Brand Name: RP Prosthetic Screw Titanium
Version or Model: 904170
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549110542
Issuing Agency: GS1
Commercial Distribution End Date: October 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: For use with Natural Profile and UCLA-Type Abutments. Install with large external hex drivers (.048").

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
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K892124	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 1ea69a4c-5481-491a-bc35-54697caf9800
Public Version Date: October 09, 2023
Public Version Number: 3
DI Record Publish Date: July 07, 2020