AccessGUDID - DEVICE: Preat (00842092170144)

GUDID

Device Identifier (DI) Information

Brand Name: Preat
Version or Model: 1500610
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1500610
Company Name: Preat Corporation

Primary DI Number: 00842092170144
Issuing Agency: GS1
Commercial Distribution End Date: August 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 117776048 *Terms of Use

Device Description: O-Ring Mini Implant Servicing Kit. kit contains . 2 O-Ring Black Rings #2 Micro Single . 1 O-Ring Yellow Processing #2 Micro Single . 1 O-Ring Purple Rings MH-2 Extra Strong Single. 1 O-Ring Closed Metal Housing #2 MH-2. 1 O-Ring Mini Implant Analog. 1 O-Ring Mini Implant Impression Coping

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?
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
NDP	Accessories, implant, dental, endosseous

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: 26a82bc2-aad8-4f25-9359-54e3d5ab820e
Public Version Date: January 11, 2024
Public Version Number: 5
DI Record Publish Date: October 25, 2022