| Primary Device ID | 00763000583682 |
| NIH Device Record Key | 6d0a0e4e-6b9d-4e2c-9737-27b2ee0532e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Instruments |
| Version Model Number | 5597501 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000583682 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
[00763000583682]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-02 |
| Device Publish Date | 2022-07-25 |
| 00763000583439 | BENDER 5596008 IN-SITU 4.75/5.0 LEFT |
| 00763000583422 | BENDER 5596007 IN-SITU 4.75/5.0 RIGHT |
| 00763000583415 | BENDER 5596006 IN-SITU 5.5-6.35 LEFT |
| 00763000583408 | BENDER 5596005 IN-SITU 5.5-6.35 RIGHT |
| 00763000585006 | DRIVER 5598051 N/BRK-OFF SET SCR REDUCER |
| 00763000584993 | DRIVER 5598048 NON-BREAK-OFF PROVISIONAL |
| 00763000584986 | DRIVER 5598047 NON-BREAK-OFF SWIZZLE |
| 00763000584979 | SLEEVE 5597545 RED HEAD DEROTATION |
| 00763000584962 | REDUCER 5597510 CLOSED |
| 00763000584955 | REDUCER 5597500 OPEN |
| 00763000584948 | DRIVER 5597185 T-HANDLE MT25 |
| 00763000584931 | DRIVER 5597070 BRK-OFF SET SCREW REDUCER |
| 00763000583750 | HEAD INSERTER 5599130 LOCKING |
| 00763000583743 | DRIVER 5598049 NON-BREAK-OFF FINAL |
| 00763000583736 | SLEEVE 5597740 STABILIZATION GUIDE |
| 00763000583705 | INSTRUMENT 5597550 SHANK EXTENDER |
| 00763000583699 | ADAPTER 5597520 SMARTLINK |
| 00763000583682 | REDUCER 5597501 THREADED-INNER |
| 00763000583675 | REDUCER 5597450 MDX BEALE ROCKER HOLES |
| 00763000583668 | ROD BENDER 5597255 ACUTE ANGLE |
| 00763000583651 | ROD BENDER 5597250 FRENCH-DUAL SIDED |
| 00763000583644 | HEAD TURNER 5597180 INLINE |
| 00763000583637 | HOOK TRIAL 5597178 WIDE BLADE L |
| 00763000583620 | HOOK TRIAL 5597177 WIDE BLADE S-M |
| 00763000583613 | HOOK TRIAL 5597176 OFFSET L-R |
| 00763000583606 | HOOK TRIAL 5597175 TRANSVERSE L-R |
| 00763000583590 | HOOK TRIAL 5597174 TAH TRV PROC S-M |
| 00763000583583 | HOOK TRIAL 5597173 EXTENDED BODY M-L |
| 00763000583576 | HOOK TRIAL 5597172 NARROW BLADE S-M |
| 00763000583569 | HOOK TRIAL 5597171 PEDICLE S-M |
| 00763000583552 | HOLDER 5597170 LATERAL IMPLANT |
| 00763000583545 | TOOL 5597160 DECORTICATION |
| 00763000583538 | TAB BREAKER 5597141 RETAINING |
| 00763000583521 | COUNTERTORQUE 5597120 MANUAL RED PLS PKT |
| 00763000583514 | HEAD INSERTER 5597110 PROVISIONAL |
| 00763000583507 | GRIPPER 5597060 6.0/6.35 ROD |
| 00763000583491 | GRIPPER 5597055 5.5 ROD |
| 00763000583484 | GRIPPER 5597050 4.75/5.0 ROD |
| 00763000583460 | PROBE 5597030 PEDICLE SMALL |
| 00763000583453 | INSTRUMENT 5597027 UAS DIRECTION GUIDE |
| 00763000583446 | HEAD TURNER 5597020 OFFSET |
| 00763000845025 | TOOL 5596048 DRIVER ASSEMBLY TOOL |
| 00763000862992 | HANDLE X981000501 GUIDE X HANDLE SHORT |
| 00763000862985 | DRIVER X981000138 25DEG T25 DRIVER |
| 00763000862978 | DRIVER X981000038 RETAINING 25 DEG T25 |
| 00763000862961 | DRIVER X981000137 BALL JOINT T25 DRIVER |
| 00763000862954 | DRIVER X981000037 RETAINING BALL JNT T25 |
| 00763000862947 | DRIVER X981000136 40DEG T25 DRIVER |
| 00763000862930 | DRIVER X981000036 RETAINING 40 DEG T25 |
| 00763000862916 | AWL X981000035 AWL ANGLED |