Isodur® NK769K

GUDID 04046963973049

ISODUR PROSTHESIS HEAD 12/14 40MM S

Aesculap AG

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis

• Primary Device ID: 04046963973049
• NIH Device Record Key: 4772bafd-9aec-4f49-85f9-946d7e96c3e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isodur®
• Version Model Number: NK769K
• Catalog Number: NK769K
• Company DUNS: 315018218
• Company Name: Aesculap AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• 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(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com
• Phone: +1(888)229-3002
• Email: setworld_orders@aesculap.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04046963973049 [Primary]

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

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: 2020-09-09
• Device Publish Date: 2015-11-11

On-Brand Devices [Isodur®]

• 04046963973087: ISODUR PROSTHESIS HEAD 12/14 40MM XXL
• 04046963973070: ISODUR PROSTHESIS HEAD 12/14 40MM XL
• 04046963973063: ISODUR PROSTHESIS HEAD 12/14 40MM L
• 04046963973056: ISODUR PROSTHESIS HEAD 12/14 40MM M
• 04046963741211: ISODUR PROSTHESIS HEAD 8/10 36MM XXL
• 04046963741204: ISODUR PROSTHESIS HEAD 8/10 36MM XL
• 04046963741198: ISODUR PROSTHESIS HEAD 8/10 36MM L
• 04046963741181: ISODUR PROSTHESIS HEAD 8/10 36MM M
• 04046963741174: ISODUR PROSTHESIS HEAD 8/10 36MM S
• 04046963741167: ISODUR PROSTHESIS HEAD 12/14 36MM XXL
• 04046963741150: ISODUR PROSTHESIS HEAD 12/14 36MM XL
• 04046963741143: ISODUR PROSTHESIS HEAD 12/14 36MM L
• 04046963741136: ISODUR PROSTHESIS HEAD 12/14 36MM M
• 04046963741129: ISODUR PROSTHESIS HEAD 12/14 36MM S
• 04038653304509: ISODUR PROSTHESIS HEAD 8/10 32MM XXL
• 04038653304394: ISODUR PROSTHESIS HEAD 8/10 32MM XL
• 04038653304387: ISODUR PROSTHESIS HEAD 8/10 32MM L
• 04038653304370: ISODUR PROSTHESIS HEAD 8/10 32MM M
• 04038653304363: ISODUR PROSTHESIS HEAD 8/10 32MM S
• 04038653206728: ISODUR PROSTHESIS HEAD 8/10 28MM XXL
• 04038653119974: ISODUR PROSTHESIS HEAD 12/14 32MM XXL
• 04038653119967: ISODUR PROSTHESIS HEAD 12/14 32MM XL
• 04038653119950: ISODUR PROSTHESIS HEAD 12/14 32MM L
• 04038653119943: ISODUR PROSTHESIS HEAD 12/14 32MM M
• 04038653119936: ISODUR PROSTHESIS HEAD 12/14 32MM S
• 04038653119806: ISODUR PROSTHESIS HEAD 12/14 28MM XXL
• 04038653119790: ISODUR PROSTHESIS HEAD 12/14 28MM XL
• 04038653119783: ISODUR PROSTHESIS HEAD 12/14 28MM L
• 04038653119776: ISODUR PROSTHESIS HEAD 12/14 28MM M
• 04038653119769: ISODUR PROSTHESIS HEAD 12/14 28MM S
• 04038653119547: ISODUR PROSTHESIS HEAD 12/14 22.2MM L
• 04038653119530: ISODUR PROSTHESIS HEAD 12/14 22.2MM M
• 04038653117949: ISODUR PROSTHESIS HEAD 8/10 28MM XL
• 04038653117932: ISODUR PROSTHESIS HEAD 8/10 28MM L
• 04038653117925: ISODUR PROSTHESIS HEAD 8/10 28MM M
• 04038653117918: ISODUR PROSTHESIS HEAD 8/10 28MM S
• 04038653117864: ISODUR PROSTHESIS HEAD 8/10 22.2MM L
• 04038653117857: ISODUR PROSTHESIS HEAD 8/10 22.2MM M
• 04038653117840: ISODUR PROSTHESIS HEAD 8/10 22.2MM S
• 04046963973049: ISODUR PROSTHESIS HEAD 12/14 40MM S