TRU and PUR 5.0mm Tap

GUDID 00841549114878

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 ID	00841549114878
NIH Device Record Key	270392c2-717c-4b49-b1cc-ea2fd8fb9e8a
Commercial Distribution Status	In Commercial Distribution
Brand Name	TRU and PUR 5.0mm Tap
Version Model Number	905296
Company DUNS	124763728
Company Name	STERNGOLD DENTAL LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549114878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150968

FDA Product Code

DZI	Drill, Bone, Powered