implaFit® trial neck K12/14 std. stem
GUDID 04048844525590
implantcast GmbH
Femoral head prosthesis trial| Primary Device ID | 04048844525590 |
| NIH Device Record Key | c30dde8a-93ee-4276-b333-0323a6664212 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | implaFit® trial neck K12/14 std. stem |
| Version Model Number | 80083010 |
| Company DUNS | 324369826 |
| Company Name | implantcast GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048844525590 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210678
FDA Product Code
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
[04048844525590]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-02 |
| Device Publish Date | 2022-08-25 |
On-Brand Devices [implaFit® trial neck K12/14 std. stem]
| 04048844525590 | 80083010 |
| 04048844525583 | 80083089 |
| 04048844525576 | 80083067 |
| 04048844525569 | 80083045 |
| 04048844525552 | 80083023 |
| 04048844525545 | 80083001 |
Trademark Results [implaFit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPLAFIT 88302985 not registered Live/Pending |
implantcast GmbH 2019-02-15 |
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