Bigliani/Flatow® 00-4300-052-27
GUDID 00889024264151
Zimmer, Inc.
Stem-fixed humeral head prosthesis| Primary Device ID | 00889024264151 |
| NIH Device Record Key | a4649bda-1efa-4c32-bd41-86a3955ba965 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® |
| Version Model Number | 4300-52-27 |
| Catalog Number | 00-4300-052-27 |
| 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
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024264151 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982981
FDA Product Code
| KWT | PROSTHESIS, SHOULDER, NON-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 | 4 |
| Public Version Date | 2019-10-09 |
| Device Publish Date | 2015-09-24 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.