10085

GUDID 20845854037055

ULTRAFIX INSERTER

Conmed Corporation

Orthopaedic implant driver
Primary Device ID20845854037055
NIH Device Record Keye72ee79c-15aa-48c4-a0d5-3fdef74fe000
Commercial Distribution StatusIn Commercial Distribution
Version Model Number10085
Catalog Number10085
Company DUNS071595540
Company NameConmed Corporation
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 Datetrue
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(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110845854037058 [Primary]
GS120845854037055 [Direct Marking]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


[20845854037055]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-09-28
Device Publish Date2020-09-24

Devices Manufactured by Conmed Corporation

10653405986362 - CONMED2026-01-26 Universal Modular Base Cart
30653405986373 - CONMED2026-01-26 Universal Modular Cart, Cord Wraps
20653405990182 - CONMED2026-01-26 Universal Cart Strap
10653405990734 - Hall® Titan™2026-01-06 Hall® Titan™ XE Single Trigger Battery Handpiece
10653405990741 - Hall® Titan™2026-01-06 Hall® Titan™ XE Dual Trigger Battery Handpiece
30653405990714 - Infinity2025-12-09 Infinity Retro-Reamer, 10.5 mm
30653405990707 - BioBrace2025-11-25 BioBrace Extra-Articular Ligament Augmentation Kit
00810021867373 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 2.7X14.0MM, 2-Pack

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.