McGee

GUDID 00681490035569

PROSTHESIS 1156330 MCGEE PISTN .6 X 3.75

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00681490035569
• NIH Device Record Key: 78c89cba-242c-44fb-8087-2aae7155f987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McGee
• Version Model Number: 1156330
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• 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	00681490035569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823440

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-24

On-Brand Devices [McGee]

• 00681490035682: PROSTHESIS 1156348 MCGEE PISTON .5X5.0
• 00681490035675: PROSTHESIS 1156347 MCGEE PISTON .5X4.75
• 00681490035668: PROSTHESIS 1156346 MCGEE PISTON .5X4.5
• 00681490035651: PROSTHESIS 1156344 MCGEE PISTON .5X4.75
• 00681490035644: PROSTHESIS 1156343 MCGEE PISTON .5X4.5
• 00681490035637: PROSTHESIS 1156342 MCGEE PISTON .5X4.25
• 00681490035620: PROSTHESIS 1156341 MCGEE PISTON .5X4.0
• 00681490035613: PROSTHESIS 1156340 MCGEE PISTON .5X3.75
• 00681490035606: PROSTHESIS 1156334 MCGEE PISTON .6X4.75
• 00681490035590: PROSTHESIS 1156333 MCGEE PISTON .6X4.5
• 00681490035583: PROSTHESIS 1156332 MCGEE PISTON .6X4.25
• 00681490035576: PROSTHESIS 1156331 MCGEE PISTON .6X4.0
• 00681490035569: PROSTHESIS 1156330 MCGEE PISTN .6 X 3.75
• 00681490035200: PROSTHESIS 1156213 MCGEE MOD .5X4.5MM
• 00681490035194: PROSTHESIS 1156212 MCGEE MOD .5X4.25MM
• 00681490035187: PROSTHESIS 1156211 MCGEE MOD .5X4.0MM
• 00681490035170: PROSTHESIS 1156210 MCGEE MOD .5X3.75MM
• 20681490035211: PROSTHESIS 1156214 MCGEE MOD .5X4.75MM