M/DN®
GUDID 00889024042766
Zimmer, Inc.
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 00889024042766 |
| NIH Device Record Key | ab2b9c5e-7c41-4750-9f70-a45bbdf96287 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M/DN® |
| Version Model Number | 2253-22-55 |
| 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 | 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
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 22.5 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024042766 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142281
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-10 |
On-Brand Devices [M/DN®]
Trademark Results [M/DN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M/DN 75241965 2166590 Live/Registered |
ZIMMER, INC 1997-02-14 |
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