Bigliani/Flatow® 00-4303-075-01
GUDID 00889024266360
Zimmer, Inc.
Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00889024266360 |
| NIH Device Record Key | 093e28de-c3e9-4587-b60b-3a4e55907f28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® |
| Version Model Number | 4303-75-01 |
| Catalog Number | 00-4303-075-01 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024266360 [Primary] |
| GS1 | 70889024266369 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103404
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2016-08-11 |
On-Brand Devices [Bigliani/Flatow®]
Trademark Results [Bigliani/Flatow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIGLIANI/FLATOW 75577076 2369417 Live/Registered |
ZIMMER, INC. 1998-10-26 |
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