TRU and PUR 3.5mm Tap

GUDID 00841549114854

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 Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable
Primary Device ID00841549114854
NIH Device Record Keyc052f5ca-0e09-44a1-8ce8-40b3b5373801
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRU and PUR 3.5mm Tap
Version Model Number905293
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

Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549114854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


[00841549114854]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2017-07-05

Devices Manufactured by STERNGOLD DENTAL LLC

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
00841549119224 - Stern Snap One Piece Abutment 5mm 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
00841549119231 - Stern Snap Abutment Base 2.4mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119248 - Stern Snap Abutment Base 3.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119255 - Stern Snap Abutment Base 4.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota

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