OsseoFit™ Stemless Shoulder 00-5381-008-02
GUDID 00889024679238
Zimmer, Inc.
Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00889024679238 |
| NIH Device Record Key | 05d1e542-ccd5-49eb-8413-443d37945061 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsseoFit™ Stemless Shoulder |
| Version Model Number | 00-5381-008-02 |
| Catalog Number | 00-5381-008-02 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| 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 | 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
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024679238 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241873
FDA Product Code
| PKC | Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
[00889024679238]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-26 |
| Device Publish Date | 2024-12-18 |
On-Brand Devices [OsseoFit™ Stemless Shoulder]
Trademark Results [OsseoFit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSEOFIT 97924878 not registered Live/Pending |
Zimmer, Inc. 2023-05-08 |
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