Affixus® 211304014
GUDID 00887868582400
Zimmer, Inc.
Orthopaedic implant aiming arm| Primary Device ID | 00887868582400 |
| NIH Device Record Key | 8ed2f13a-e424-4d0b-a0cd-8b7d5a3af3a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affixus® |
| Version Model Number | 211304014 |
| Catalog Number | 211304014 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868582400 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241651
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
[00887868582400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-24 |
| Device Publish Date | 2024-10-16 |
On-Brand Devices [Affixus®]
Trademark Results [Affixus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFIXUS 77944955 3912289 Live/Registered |
BIOMET C.V. 2010-02-25 |
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