Bigliani/Flatow® 00-4301-006-01
GUDID 00889024264458
Zimmer, Inc.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00889024264458 |
| NIH Device Record Key | 9a737e0d-4c92-4ae8-ac37-363de9f58733 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® |
| Version Model Number | 4301-06-01 |
| Catalog Number | 00-4301-006-01 |
| 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
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
| Device Size Text, specify | 0 |
| Length | 178 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024264458 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110791
FDA Product Code
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
[00889024264458]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-09 |
| 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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