FDA.reportPublic FDA data

Zimmer

Primary DI
00842092100486
Brand
Zimmer
Company
Preat Corporation
Model
8000151
Catalog number
8000151
Device description
Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin 20mm
Published
2023-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092100486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092100486008420921004868420921004860842092100486

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screw analog, single-useA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Some types are referred to as a guide pin, and may be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092184301Preat7100107100102025-12-22
00842092184370Preat7100207100202025-12-22
00842092185391Preat7105407105402025-12-22
00842092185414Preat7105427105422025-12-22
00842092185421Preat7105437105432025-12-22
00842092185438Preat7105447105442025-12-22
00842092185445Preat7105457105452025-12-22
00842092185452Preat7105507105502025-12-22
00842092184257Preat7101717101712025-07-24
00842092184394Preat7100227100222025-07-24
00842092184400Preat7100237100232025-07-24
00842092184417Preat7100247100242025-07-24
00842092184424Preat7100257100252025-07-24
00842092184448Preat7100327100322025-07-24
00842092184455Preat7100337100332025-07-24
00842092184462Preat7100347100342025-07-24
00842092184516Preat7102217102212025-07-24
00842092184561Preat7107117107112025-07-24
00842092184578Preat7107127107122025-07-24
00842092184585Preat7107137107132025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01