Consensus Hip System/UniSyn Hip System 4430-10010-A

GUDID 00840286841580

8mm Starter Drill, UniSyn

Shalby Advanced Technologies, Inc.

Fluted surgical drill bit, reusable
Primary Device ID00840286841580
NIH Device Record Key6ab23c97-10e4-4262-b1a4-fc849720d1d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameConsensus Hip System/UniSyn Hip System
Version Model Number4430-10010-A
Catalog Number4430-10010-A
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100840286841580 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


[00840286841580]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-30
Device Publish Date2025-05-22

On-Brand Devices [Consensus Hip System/UniSyn Hip System]

00840286841597Slap Hammer, UniSyn
008402868415808mm Starter Drill, UniSyn

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