Stern IC Surgical Kit

GUDID 08415491139313

The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.

STERNGOLD DENTAL LLC

Dental/maxillofacial surgical procedure kit, medicated, reusable
Primary Device ID08415491139313
NIH Device Record Keyf7430f63-1274-41c2-bff1-815340630539
Commercial Distribution StatusIn Commercial Distribution
Brand NameStern IC Surgical Kit
Version Model Number905728
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491139313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491139313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-07-05

On-Brand Devices [Stern IC Surgical Kit]

08415491139313The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone
00841549115264The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone

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