| Primary Device ID | 00840019925167 |
| NIH Device Record Key | 7855541d-91e4-498c-90ee-0707b35fb97c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ShurFit MALIF System |
| Version Model Number | 23-9001 |
| Catalog Number | 23-9001 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| 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 | 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 | 00840019925167 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019925167]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-05 |
| Device Publish Date | 2019-03-28 |
| 00840019925501 | ShurFit™ MALIF Implant Case (Empty) |
| 00840019925495 | ShurFit™ MALIF Instrument Case # 2 (Empty) |
| 00840019925488 | ShurFit™ MALIF Instrument Case # 1 (Empty) |
| 00840019925471 | MALIF Sizer 22x50x14mm |
| 00840019925464 | MALIF Sizer 22x50x12mm |
| 00840019925457 | MALIF Sizer 22x50x10mm |
| 00840019925440 | MALIF Sizer 22x50x08mm |
| 00840019925433 | MALIF Sizer 18x50x14mm |
| 00840019925426 | MALIF Sizer 18x50x12mm |
| 00840019925402 | MALIF Sizer 18x50x08mm |
| 00840019925396 | Angled Cobb 22mm |
| 00840019925365 | Straight Cobb 18mm |
| 00840019925358 | Large Chisel 12mm Width |
| 00840019925341 | Small Chisel 6mm Width |
| 00840019925334 | Paddle Shaver 50mm Length x 14mm Height |
| 00840019925303 | Paddle Shaver 50mm Length x 08mm Height |
| 00840019925297 | Paddle Shaver 50mm Length x 06mm Height |
| 00840019925273 | Cup Curette 6mm x 90˚ Up Pulling |
| 00840019925266 | Cup Curette 6mm x 45˚Up Pulling |
| 00840019925235 | Cup Curette 4mm x 45˚ Up Pulling |
| 00840019925211 | Disc Spreader |
| 00840019925181 | Implant Slides |
| 00840019925174 | Implant Extractor |
| 00840019925150 | Box Curette 8mm |
| 00840019925136 | Ring Curette 8mm Large |
| 00840019925129 | Ring Curette 6mm Small |
| 00840019925112 | Rasp |
| 00840019916387 | Rongeurs Pituitary Straight Kerrison 6mm x 330mm |
| 00840019916370 | Rongeurs Pituitary Straight Kerrison 4mm x 330mm |
| 00840019916363 | Punch Kerrison Lamina 40˚ Up Bite 6mm x 330mm |
| 00840019916356 | Punch Kerrison Lamina 40˚ Up Bite 4mm x 330mm |
| 00840019925419 | MALIF Sizer 18x50x10mm |
| 00840019925327 | Paddle Shaver 50mm Length x 12mm Height |
| 00840019925310 | Paddle Shaver 50mm Length x 10mm Height |
| 00840019925280 | T Handle Quick Connect |
| 00840019925259 | Cup Curette 6mm Straight Up Cup |
| 00840019925242 | Cup Curette 4mm 90˚ Up Pulling |
| 00840019925228 | Cup Curette 4mm Straight Up Cup |
| 00840019925204 | LLIF Slap Hammer |
| 00840019925198 | LLIF Tamp |
| 00840019925167 | LLIF Inserter Tool |
| 00840019925143 | Box Curette 6mm |