Biolox® Option NK638
GUDID 04046963182076
BIOLOX DELTA REVISION HEAD 12/14 36MM XL
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| Primary Device ID | 04046963182076 |
| NIH Device Record Key | 4240fd93-14fb-43ce-b939-f18f1ef42185 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biolox® Option |
| Version Model Number | NK638 |
| Catalog Number | NK638 |
| 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 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.com | |
| Phone | +1(888)229-3002 |
| setworld_orders@aesculap.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 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 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 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 | 04046963182076 [Primary] |
FDA Product Code
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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 | 2015-09-24 |
On-Brand Devices [Biolox® Option]
| 04046963182076 | BIOLOX DELTA REVISION HEAD 12/14 36MM XL |
| 04046963182069 | BIOLOX DELTA REVISION HEAD 12/14 36MM L |
| 04046963182052 | BIOLOX DELTA REVISION HEAD 12/14 36MM M |
| 04046963182045 | BIOLOX DELTA REVISION HEAD 12/14 36MM S |
| 04038653434114 | BIOLOX DELTA REVISION HEAD 12/14 32MM XL |
| 04038653434107 | BIOLOX DELTA REVISION HEAD 12/14 32MM L |
| 04038653434091 | BIOLOX DELTA REVISION HEAD 12/14 32MM M |
| 04038653434084 | BIOLOX DELTA REVISION HEAD 12/14 32MM S |
| 04038653434077 | BIOLOX DELTA REVISION HEAD 12/14 28MM XL |
| 04038653434060 | BIOLOX DELTA REVISION HEAD 12/14 28MM L |
| 04038653434053 | BIOLOX DELTA REVISION HEAD 12/14 28MM M |
| 04038653434046 | BIOLOX DELTA REVISION HEAD 12/14 28MM S |
Trademark Results [Biolox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOLOX 79278180 not registered Live/Pending |
Cerasiv GmbH Innovatives Keramik-Engineering 2019-09-24 |
 BIOLOX 73078031 1068905 Live/Registered |
FELDMUHLE ANLAGEN- UND PRODUKTIONS-GMBH 1976-02-23 |
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