Primary Device ID | 00840916151645 |
NIH Device Record Key | 43741ffd-6d71-4d86-88a5-585074937439 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Savannah |
Version Model Number | 11000-59 |
Company DUNS | 004022104 |
Company Name | SPINAL ELEMENTS |
Device Count | 1 |
DM Exempt | true |
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 | 00840916151645 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
[00840916151645]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-24 |
Device Publish Date | 2020-04-16 |
00840916135836 | 90° CURVED ROD INSERTER BODY |
00840916135829 | 90° CURVED ROD INSERTER SHAFT |
00840916155919 | IMP PLATE FOR LO-TOP/MID-TOP TRAY BOTTOM LEVEL |
00840916155902 | IMP PLATE FOR LO-TOP/MID-TOP TRAY |
00840916149901 | DUAL FIX SCREW CADDY |
00840916160722 | K-WIRE TUBE |
00840916160715 | INGE LAMINA SPREADER, LARGE 10" |
00840916160692 | NOTCHED PEDICLE MARKER |
00840916160685 | SOLID PEDICLE MARKER |
00840916155926 | DUAL STYLET NEEDLE, DIAMOND AND BEVEL TIP, 11 G X 15CM |
00840916151669 | LARGE T-HANDLE WITH AO CONNECTION GAUTHIER (G308532) |
00840916151645 | ROD INSERTER DRIVER |
00840916151454 | PEDICLE DRILL GUIDE |
00840916150938 | DRILL GUIDE, MIDLINE |
00840916150303 | COMBINATION, PEDICLE-DRILL |
00840916150297 | PEDICLE-DRILL, MIDLINE |
00840916150280 | SET SCREW INSERTER |
00840916150273 | MIS CONNECTOR INSERTER |
00840916150266 | ROD BENDER |
00840916150259 | AXIAL HANDLE - RATCHETING |
00840916150242 | T-HANDLE |
00840916150235 | TORQUE LIMITING T-HANDLE |
00840916150228 | PEDICLE FEELER |
00840916150211 | COUPLER PUSHER ASSEMBLY |
00840916150204 | STABILIZER |
00840916150198 | CANNULATED TAP |
00840916150181 | CANNULATED TAP WITH QUICK CONNECT |
00840916150174 | CANNULATED TAP |
00840916150167 | HEX RETAINER |
00840916150150 | CANNULATED HEX DRIVER |
00840916150143 | CROW FOOT SIDEBAR |
00840916150136 | CROW FOOT |
00840916150129 | SQUARE DRIVER |
00840916150112 | FLUTED AWL |
00840916150105 | TAPPING AWL |
00840916150099 | HEX DRIVER |
00840916150082 | POST REMOVER |
00840916150075 | 8.5" PLUNGER |
00840916150068 | STRAIGHT ROD HOLDING FORCEPS 5.5MM |
00840916150051 | MISCELLANEOUS CADDY 4.00 X 7.40 X 1.13IN |
00840916149840 | HEX ADAPTER |
00840916160777 | SAVANNAH-T MIS PEDICLE SCREW TAP 6.5MM |
00840916160753 | MEDIAL SET SCREW SLEEVE |
00840916160746 | COMBINATION ROD BENDERS RIGHT |
00840916160739 | COMBINATION ROD BENDERS LEFT |
00840916150440 | 90° CURVED ROD INSERTER |
00840916150433 | SHORT RIGHT ANGLE ROD INSERTER |
00840916150426 | SET SCREW DRIVER WITH FRICTION FIT |
00840916150419 | MIS TULIP POSITIONER |
00840916150396 | 18 INCH PEDICLE SCREW DEPTH GAUGE |