Causse

GUDID 00763000034238

PROSTHESIS 0321 H/A NOTCHED OFFSET TOTAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000034238
• NIH Device Record Key: 88386f5b-01fd-48df-b78d-3aad97985e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Causse
• Version Model Number: 0321
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031786

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

On-Brand Devices [Causse]

• 00681490264402: PROSTHESIS EN0002 CAUSSE FOOTPLT FLEX HA
• 00681490195775: PROSTHESIS 9131002 CAUSSE LOOP 4.75MM
• 00681490195768: PROSTHESIS 9131001 CAUSSE LOOP 4.6MM
• 00681490035750: PROSTHESIS 1156376 CAUSSE FLPL PARTIAL
• 00681490035521: PROSTHESIS 1156316 CAUSSE PISTON .6X6
• 00681490035514: PROSTHESIS 1156314 CAUSSE PISTON .4X6
• 00681490035293: PROSTHESIS 1156241 CAUSSE PISTON .4X6.0
• 00681490034593: PROSTHESIS 1133210 POLYCEL BUCKET .4X8.0
• 00681490034579: PROSTHESIS 1133191 CAUSSE MALLEUS LOOP
• 00681490034241: PROSTHESIS 1129070 CAUSSE LP .8X.8DX5L
• 00681490034234: PROSTHESIS 1129065 CAUSSE LP .8X.8DX4.5L
• 00681490034227: PROSTHESIS 1129055 CAUSSE LP .8X.6DX6L
• 00681490034210: PROSTHESIS 1129050 CAUSSE LP .8X.6DX5L
• 00681490034203: PROSTHESIS 1129045 CAUSSE LP .8X.6DX4.5L
• 00681490034197: PROSTHESIS 1129040 CAUSSE LP .8X.6DX4L
• 00681490034180: PROSTHESIS 1129030 CAUSSE LP .8X.3X6MM L
• 00681490034173: PROSTHESIS 1129020 CAUSSE LP .8X.3X5MM L
• 00681490034166: PROSTHESIS 1129015 CAUSSE LP .8X.3X4.5L
• 00681490034159: IMPLANT 1128450 CAUSSE STAPES SHEET FLPL
• 00681490033602: PROSTHESIS 1112197 CAUSSE MALLEUS PARTL
• 00681490033596: PROSTHESIS 1112195 CAUSSE CAM TOTAL
• 00681490033589: PROSTHESIS 1112194 CAUSSE DELTA TOTAL
• 00681490033572: PROSTHESIS 1112192 CAUSSE MUSHRM TOTAL
• 00681490033565: PROSTHESIS 1112190 CAUSSE MALLEUS TOTAL
• 00681490024938: PROSTHESIS 0585 TRIAX INCUS NECROSIS
• 00681490024181: PROSTHESIS 0529 CAUSSE FLEX H/A TOTAL
• 00681490024174: PROSTHESIS 0528 CAUSSE MINI HD PARTIAL
• 00681490024167: PROSTHESIS 0527 CAUSSE H/A MINI HD TOTAL
• 00681490024150: PROSTHESIS 0526 CAUSSE FLEX H/A PARTIAL
• 00681490024143: PROSTHESIS 05251 CAUSSE TOTAL W/WIRE
• 00681490024136: PROSTHESIS 0525 CAUSSE FLEX H/A OFF TOTL
• 00681490024006: PROSTHESIS 0518 CAUSSE FLEX H/A OFF TOT
• 00681490017688: PROSTHESIS 0322 CAUSSE STAPES REV TOTAL
• 00681490017671: PROSTHESIS 0321 H/A NOTCHED OFFSET TOTAL
• 00721902997969: PROSTHESIS 0586 CAUSSE/PARAHY FLX HA TOT
• 00763000035426: PROSTHESIS 1156316 CAUSSE PISTON .6X6
• 00763000035419: PROSTHESIS 1156314 CAUSSE PISTON .4X6
• 00763000035358: PROSTHESIS 1156241 CAUSSE PISTON .4X6.0
• 00763000035204: PROSTHESIS 1133191 CAUSSE MALLEUS LOOP
• 00763000035075: PROSTHESIS 1129070 CAUSSE LP .8X.8DX5L
• 00763000035068: PROSTHESIS 1129065 CAUSSE LP .8X.8DX4.5L
• 00763000035051: PROSTHESIS 1129055 CAUSSE LP .8X.6DX6L
• 00763000035044: PROSTHESIS 1129050 CAUSSE LP .8X.6DX5L
• 00763000035037: PROSTHESIS 1129045 CAUSSE LP .8X.6DX4.5L
• 00763000035020: PROSTHESIS 1129040 CAUSSE LP .8X.6DX4L
• 00763000035013: PROSTHESIS 1129030 CAUSSE LP .8X.3X6MM L
• 00763000035006: PROSTHESIS 1129020 CAUSSE LP .8X.3X5MM L
• 00763000034993: PROSTHESIS 1129015 CAUSSE LP .8X.3X4.5L
• 00763000034795: PROSTHESIS 1112195 CAUSSE CAM TOTAL
• 00763000034788: PROSTHESIS 1112190 CAUSSE MALLEUS TOTAL