PUR® 3.2mm Tap

GUDID 00841549114748

A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes.

STERNGOLD DENTAL LLC

Bone tap, reusable
Primary Device ID00841549114748
NIH Device Record Keyec1a9223-a656-4314-b5f4-1d7de39aa97d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUR® 3.2mm Tap
Version Model Number905256
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549114748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


[00841549114748]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-08
Device Publish Date2020-06-01

Devices Manufactured by STERNGOLD DENTAL LLC

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00841549115882 - Hader2024-12-05 Hader Vertical Males Only, 6
00841549119187 - Stern Snap One Piece Abutment 1mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t

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