Bigliani/Flatow® Trabecular Metal™ 00-4327-040-00
GUDID 00889024268500
Zimmer, Inc.
Shoulder glenoid fossa prosthesis trial| Primary Device ID | 00889024268500 |
| NIH Device Record Key | 78f2f3c6-3679-4f28-b566-fd2bd146dd58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® Trabecular Metal™ |
| Version Model Number | 00-4327-040-00 |
| Catalog Number | 00-4327-040-00 |
| 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 | 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 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 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 | 00889024268500 [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 |
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
[00889024268500]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-10-09 |
| Device Publish Date | 2016-07-14 |
On-Brand Devices [Bigliani/Flatow® Trabecular Metal™]
| 00889024274266 | 47-4307-61 |
| 00889024274242 | 47-4307-31 |
| 00889024268586 | 00-4327-052-56 |
| 00889024268579 | 00-4327-052-46 |
| 00889024268562 | 00-4327-052-00 |
| 00889024268555 | 00-4327-046-52 |
| 00889024268548 | 00-4327-046-40 |
| 00889024268531 | 00-4327-046-00 |
| 00889024268524 | 00-4327-044-00 |
| 00889024268517 | 00-4327-040-46 |
| 00889024268500 | 00-4327-040-00 |
| 00889024268494 | 00-4327-032-52 |
| 00889024268487 | 00-4327-032-46 |
| 00889024268470 | 00-4327-032-40 |
| 00889024266797 | 4307-74 |
| 00889024266759 | 4307-64 |
| 00889024266742 | 4307-63 |
| 00889024266735 | 4307-62 |
| 00889024266728 | 4307-43 |
| 00889024266711 | 4307-42 |
| 00889024266704 | 4307-38 |
| 00889024266698 | 4307-35-52 |
| 00889024266681 | 4307-35-46 |
| 00889024266674 | 4307-35-40 |
| 00889024266667 | 4307-33 |
| 00889024266650 | 4307-32-52 |
| 00889024266643 | 4307-32-46 |
| 00889024266636 | 4307-32-40 |
| 00889024265585 | 00-4301-098-50 |
| 00889024274259 | 47-4307-41 |
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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