Bigliani/Flatow®
GUDID 00889024264342
Zimmer, Inc.
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 00889024264342 |
| NIH Device Record Key | 5ab94a8d-2efa-4233-a65a-514f8f1de413 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® |
| Version Model Number | 4301-01 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024264342 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103404
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
[00889024264342]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-28 |
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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