ACE-FISCHER®DISTRACTION WIRE 104691001
GUDID 00887868010774
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00887868010774 |
| NIH Device Record Key | 95c4bc9d-f214-42b9-b97e-d15b7193f462 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE-FISCHER®DISTRACTION WIRE |
| Version Model Number | 1046-91-001 |
| Catalog Number | 104691001 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| Device Count | 3 |
| 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 | 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)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868010774 [Primary] |
| GS1 | 70887868010773 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K801594
FDA Product Code
| HXK | HOLDER, NEEDLE; ORTHOPEDIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
[00887868010774]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
Devices Manufactured by Biomet Orthopedics, LLC
| 00889024664739 - JuggerKnot Short Rigid Reusable Guide | 2024-07-29 |
| 00889024674288 - HAMMR™ | 2024-07-03 |
| 00887868555732 - Patient Specific Planning Solution™ | 2024-06-25 |
| 00880304658462 - Compress® | 2024-05-24 |
| 00889024663794 - HAMMR™ | 2024-05-17 |
| 00889024663800 - HAMMR™ | 2024-05-17 |
| 00889024663817 - HAMMR™ | 2024-05-17 |
| 00889024663824 - HAMMR™ | 2024-05-17 |
Trademark Results [ACE-FISCHER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACE-FISCHER 73421065 1281428 Live/Registered |
Ace Orthopedic Company, Inc. 1983-04-11 |
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