P.C.A. 2642-1-111
GUDID 04546540209122
Primary Insert
Howmedica Osteonics Corp.
Tibial insert| Primary Device ID | 04546540209122 |
| NIH Device Record Key | 5f5b7b1f-c20b-4d22-8d6d-dbe2372a8914 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | P.C.A. |
| Version Model Number | 2642-1-111 |
| Catalog Number | 2642-1-111 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540209122 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972863
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [P.C.A.]
| 07613154056071 | Primary Insert |
| 07613154056064 | Primary Insert |
| 07613154056057 | Primary Insert |
| 07613154056040 | Primary Insert |
| 07613154056033 | Primary Insert |
| 07613154056026 | Primary Insert |
| 07613154056019 | Primary Insert |
| 07613154056002 | Primary Insert |
| 07613153132264 | Primary Insert |
| 04546540323163 | All Poly Patella |
| 04546540323156 | Modular Revision Insert |
| 04546540323149 | Modular Revision Insert |
| 04546540323132 | Modular Revision Insert |
| 04546540323125 | Modular Revision Insert |
| 04546540323118 | Modular Revision Insert |
| 04546540323101 | Modular Revision Insert |
| 04546540323095 | Modular Revision Insert |
| 04546540323088 | Modular Revision Insert |
| 04546540323071 | Modular Revision Insert |
| 04546540323064 | Modular Revision Insert |
| 04546540323057 | Modular Revision Insert |
| 04546540323040 | Modular Revision Insert |
| 04546540323033 | Modular Revision Insert |
| 04546540323026 | Modular Revision Insert |
| 04546540323019 | All Poly Patella |
| 04546540323002 | Modular Revision Insert |
| 04546540322999 | Modular Revision Insert |
| 04546540322982 | Modular Revision Insert |
| 04546540322975 | Modular Revision Insert |
| 04546540322968 | Modular Revision Insert |
| 04546540322951 | Modular Revision Insert |
| 04546540322944 | Modular Revision Insert |
| 04546540322937 | Modular Revision Insert |
| 04546540322920 | Modular Revision Insert |
| 04546540322913 | Modular Revision Insert |
| 04546540322906 | Modular Revision Insert |
| 04546540322890 | Modular Revision Insert |
| 04546540322883 | Modular Revision Insert |
| 04546540322876 | Modular Revision Insert |
| 04546540322869 | All Poly Patella |
| 04546540322852 | Modular Revision Insert |
| 04546540322845 | Modular Revision Insert |
| 04546540322838 | Modular Revision Insert |
| 04546540322821 | Modular Revision Insert |
| 04546540322814 | Modular Revision Insert |
| 04546540322807 | Modular Revision Insert |
| 04546540322791 | Modular Revision Insert |
| 04546540322784 | Modular Revision Insert |
| 04546540322777 | Modular Revision Insert |
| 04546540322760 | Modular Revision Insert |
Trademark Results [P.C.A.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 P.C.A. 74439970 1866870 Dead/Cancelled |
Howmedica Inc. 1993-09-24 |
 P.C.A. 73462086 1419066 Dead/Cancelled |
HOWMEDICA, INC. 1984-01-23 |
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