AccessGUDID - DEVICE: Preat Implant Prosthetics (00842092180679)

GUDID

Device Identifier (DI) Information

Brand Name: Preat Implant Prosthetics
Version or Model: 9000230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9000230
Company Name: Preat Corporation

Primary DI Number: 00842092180679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117776048 *Terms of Use
Previous DI: 00842092126431

Device Description: Zimmer® TSV-compatible 4.5mm Engaging Verification Cylinder Kit contains: 1 Zimmer® TSV-compatible 4.5mm Engaging Verification Cylinder 1 Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin 20mm 1 Zimmer® TSV-compatible 3.5mm/4.5mm/5.7mm Titanium Implant Screw

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. 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 [?]
K183518	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: 40e6cda8-595c-4b99-b5f4-c2d56be14fda
Public Version Date: February 12, 2024
Public Version Number: 3
DI Record Publish Date: August 07, 2023