UniSyn Hip System 4460-11113-A

GUDID 00840286844420

11mm, Distal Pilot, UniSyn

Shalby Advanced Technologies, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 00840286844420
• NIH Device Record Key: 4a29ab5a-f573-45c0-9b09-1b1f8164d1b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSyn Hip System
• Version Model Number: 4460-11113-A
• Catalog Number: 4460-11113-A
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286844420 [Primary]

FDA Product Code

• HTO: Reamer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

[00840286844420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

On-Brand Devices [UniSyn Hip System]

• 00840286837903: Body, Calcar, Cementless, PC, HA Coated, 30mm
• 00840286837897: Body, Calcar, Cementless, PC, HA Coated, 28mm
• 00840286837880: Body, Calcar, Cementless, PC, HA Coated, 26mm
• 00840286837873: Body, Calcar, Cementless, PC, HA Coated, 24mm
• 00840286837866: Body, Calcar, Cementless, PC, HA Coated, 22mm
• 00840286837859: Body, Calcar, Cementless, PC, Plasma, 30mm
• 00840286837842: Body, Calcar, Cementless, PC, Plasma, 30mm
• 00840286837835: Body, Calcar, Cementless, PC, Plasma, 28mm
• 00840286837828: Body, Calcar, Cementless, PC, Plasma, 28mm
• 00840286837811: Body, Calcar, Cementless, PC, Plasma, 26mm
• 00840286837804: Body, Calcar, Cementless, PC, Plasma, 26mm
• 00840286837798: Body, Calcar, Cementless, PC, Plasma, 24mm
• 00840286837781: Body, Calcar, Cementless, PC, Plasma, 24mm
• 00840286837774: Body, Calcar, Cementless, PC, Plasma, 22mm
• 00840286837767: Body, Calcar, Cementless, PC, Plasma, 22mm
• 00840286837750: Body, Calcar, Cementless, NP, Grit Blast, 30mm
• 00840286837743: Body, Calcar, Cementless, NP, Grit Blast, 28mm
• 00840286837736: Body, Calcar, Cementless, NP, Grit Blast, 26mm
• 00840286837729: Body, Calcar, Cementless, NP, Grit Blast, 24mm
• 00840286837712: Body, Calcar, Cementless, NP, Grit Blast, 22mm
• 00840286837705: Body, Standard, Cementless, PC, HA/Plasma, 32mm, 38mm
• 00840286837699: Body, Standard, Cementless, PC, HA/Plasma, 32mm, 34mm
• 00840286837682: Body, Standard, Cementless, PC, HA/Plasma, 32mm, 30mm
• 00840286837675: Body, Standard, Cementless, PC, HA/Plasma, 30mm, 38mm
• 00840286837668: Body, Standard, Cementless, PC, HA/Plasma, 30mm, 34mm
• 00840286837651: Body, Standard, Cementless, PC, HA/Plasma, 30mm, 30mm
• 00840286837644: Body, Standard, Cementless, PC, HA/Plasma, 30mm, 26mm
• 00840286837637: Body, Standard, Cementless, PC, HA/Plasma, 28mm, 34mm
• 00840286837620: Body, Standard, Cementless, PC, HA/Plasma, 28mm, 30mm
• 00840286837613: Body, Standard, Cementless, PC, HA/Plasma, 28mm, 26mm
• 00840286837606: Body, Standard, Cementless, PC, HA/Plasma, 26mm, 34mm
• 00840286837590: Body, Standard, Cementless, PC, HA/Plasma, 26mm, 30mm
• 00840286837583: Body, Standard, Cementless, PC, HA/Plasma, 26mm, 26mm
• 00840286837576: Body, Standard, Cementless, PC, HA/Plasma, 26mm, 22mm
• 00840286837569: Body, Standard, Cementless, PC, HA/Plasma, 24mm, 34mm
• 00840286837552: Body, Standard, Cementless, PC, HA/Plasma, 24mm, 30mm
• 00840286837545: Body, Standard, Cementless, PC, HA/Plasma, 24mm, 26mm
• 00840286837538: Body, Standard, Cementless, PC, HA/Plasma, 24mm, 22mm
• 00840286837521: Body, Standard, Cementless, PC, HA/Plasma, 22mm, 30mm
• 00840286837514: Body, Standard, Cementless, PC, HA/Plasma, 22mm, 26mm
• 00840286837507: Body, Standard, Cementless, PC, HA/Plasma, 22mm, 22mm
• 00840286837491: Body, Standard, Cementless, PC, Plasma, 32mm, 38mm
• 00840286837484: Body, Standard, Cementless, PC, Plasma, 32mm, 34mm
• 00840286837477: Body, Standard, Cementless, PC, Plasma, 32mm, 30mm
• 00840286837460: Body, Standard, Cementless, PC, Plasma, 30mm, 38mm
• 00840286837453: Body, Standard, Cementless, PC, Plasma, 30mm, 34mm
• 00840286837446: Body, Standard, Cementless, PC, Plasma, 30mm, 34mm
• 00840286837439: Body, Standard, Cementless, PC, Plasma, 30mm, 30mm
• 00840286837422: Body, Standard, Cementless, PC, Plasma, 30mm, 30mm
• 00840286837415: Body, Standard, Cementless, PC, Plasma, 30mm, 26mm