Primary Device ID | 00840019905596 |
NIH Device Record Key | fc603b09-2cac-476d-a14b-c59f26aeb3e3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SureLOK MIS 3L |
Version Model Number | 63-CP-7545 |
Catalog Number | 63-CP-7545 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
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 | true |
Lot Batch | false |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00840019905596 [Primary] |
MNI | Orthosis, Spinal Pedicle Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
[00840019905596]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-16 |
Device Publish Date | 2019-04-08 |
00840019920322 | Caddy, CL Straight Rod Ti, 35-90mm |
00840019920315 | Caddy, CL Straight Rod Ti, 100-150mm |
00840019920292 | Caddy, Straight Rod 100-150mm |
00840019920285 | Caddy, CL Curved Rod Titanium |
00840019920278 | Caddy, Curved Rod Titanium |
00840019920261 | Insturment Case w/ Pin Mat |
00840019920254 | Implant Case 2 |
00840019920247 | Implant Case 1 |
00840019920223 | Instrument Case - M |
00840019920216 | MIS 3L Serial Dilator, 24mm |
00840019920209 | MIS 3L Serial Dilator, 18mm |
00840019920193 | MIS 3L Serial Dilator, 13mm |
00840019920179 | CL Rod Inserter |
00840019920162 | Ring |
00840019920155 | CL Counter Torque Handle |
00840019920148 | Reduction Driver |
00840019920131 | Reducer Dock |
00840019920124 | Compression-Distraction Arm B2 |
00840019920117 | Compression-Distraction Arm B1 |
00840019920100 | Compression-Distraction Arm A |
00840019920094 | Bifurcated Tap, 8.5mm |
00840019920087 | Bifurcated Tap, 7.5mm |
00840019920070 | Bifurcated Tap, 6.5mm |
00840019920063 | Bifurcated Tap, 5.5mm |
00840019920056 | Guide Wire Inserter/Extractor |
00840019920032 | Counter Torque Handle |
00840019920025 | Compressor-Distractor Arm B |
00840019920018 | Compressor-Distractor Arm A |
00840019920001 | Reducer Extender |
00840019919999 | Rod Reducer |
00840019919982 | C-Torque, Sleeve |
00840019919975 | Bottle Cap |
00840019919951 | Torque Drive Shaft |
00840019919944 | Rod Inserter, Side Load |
00840019919920 | Percutaneous Screwdriver, Short |
00840019919913 | Tower Sleeve |
00840019919906 | Ratcheting Palm Handle |
00840019919883 | Tap Dilator |
00840019920308 | Caddy, Straight Rod 35-90mm |
00840019920230 | Instrument Case |
00840019920186 | MIS 3L Serial Dilator, 8mm |
00840019920049 | T-Handle, Reduction Tower |
00840019919968 | Tower Tube Removal Tool |
00840019919937 | Rod Inserter Tightener |
00840019919890 | Biforcated Taps |
00840019905749 | Pedicle Screw Ø8.5 x 100mm |
00840019905732 | Pedicle Screw Ø8.5 x 90mm |
00840019905725 | Pedicle Screw Ø8.5 x 80mm |
00840019905718 | Pedicle Screw Ø8.5 x 70mm |
00840019905701 | Pedicle Screw Ø8.5 x 60mm |