| Primary Device ID | 07640187915716 |
| NIH Device Record Key | 0e7be27f-2a0e-416d-9132-42cf54f0b403 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Humeral IM reamer Ø8 x 345 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup. |
| Version Model Number | T7645 |
| Catalog Number | T7645 |
| Company DUNS | 486741981 |
| Company Name | MPS Precimed SA |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07640187915716 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
[07640187915716]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-24 |
| Device Publish Date | 2020-08-14 |
| 07640187910476 - Allen key 3.5 mm | 2020-09-03 Allen key 3.5 mm is a hand-held instrument used to hold or unhold screw on the extraction clamp and the chisel handle. This is a |
| 07640187910483 - Extraction clamp | 2020-09-03 Extraction clamp is a hand-held instrument, in combination with the slap hammer, used to extract any femoral implants, as well a |
| 07640187910506 - Puncher | 2020-09-03 A hand-held instrument used to, as soon as the femoral implant has been loosed by the chisel blade, for punching out the femoral |
| 07640187910537 - Clamp | 2020-09-03 A clamp for replacement on the extraction clamp when the blade is damaged. The clamp is symmetric and therefore can be used for |
| 07640187911343 - Straight guide Ø2 x 820 mm | 2020-09-03 The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to |
| 07640187914092 - Handle for carbon offset reamer handle | 2020-09-03 The handle is proposed as accessory for the carbon offset reamer handles.This is a reusable device. |
| 07640187917161 - Offset Cup Impactor 7/16-20 UNF Long = 3mm | 2020-09-03 Offset cup impactors are to be used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement |
| 07640187910513 - Chisel handle | 2020-09-02 A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchang |