ACE-FISCHER®OLIVE WIRE 104201001
GUDID 00887868010767
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use| Primary Device ID | 00887868010767 |
| NIH Device Record Key | c85ed478-31ae-44b2-992a-f91b147b6821 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE-FISCHER®OLIVE WIRE |
| Version Model Number | 1042-01-001 |
| Catalog Number | 104201001 |
| 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 | 00887868010767 [Primary] |
| GS1 | 70887868010766 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K801594
FDA Product Code
| HTY | PIN, FIXATION, SMOOTH |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
Moist Heat or Steam Sterilization
[00887868010767]
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 |
On-Brand Devices [ACE-FISCHER®OLIVE WIRE]
| 00887868010767 | 1042-01-001 |
| 00887868001499 | 10420 |
| 00887868001482 | 10419 |
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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