AccessGUDID - DEVICE: Preat (00842092169148)

GUDID

Device Identifier (DI) Information

Brand Name: Preat
Version or Model: 1300320
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1300320
Company Name: Preat Corporation

Primary DI Number: 00842092169148
Issuing Agency: GS1
Commercial Distribution End Date: April 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 117776048 *Terms of Use

Device Description: Pin Screw 1.6mm Starter Kit . kit contains . 3 Pin screw 1.6mm Internal Hex . 1 Pin Screw 1.4mm Twist Drill . 1 Pin Screw 1.6mm Thread Cutter . 1 Pin Screw Socket Key (1300360), . 1 1.6mm Hex Driver (.035)

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:	Yes
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
EGG	ATTACHMENT, PRECISION, ALL

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: 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: a121141c-2b72-47cd-8d51-92fa7e7d173e
Public Version Date: January 11, 2024
Public Version Number: 5
DI Record Publish Date: October 24, 2022