| Primary Device ID | 00818613020489 |
| NIH Device Record Key | 9c9ddbea-4f5c-455c-967c-0143fef71bf3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | II-1-0523 |
| Catalog Number | II-1-0523 |
| Company DUNS | 080300717 |
| Company Name | INTEGRITY IMPLANTS 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818613020489 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
[00818613020489]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-08 |
| 00810004722323 | FlareHawk Universal Instrument Tray |
| 00810004721883 | Pedicle Rod Inserter |
| 00810004721746 | Handled Double Ended Set Screw Starter |
| 00810004721739 | Self Retaining Screw Driver - Split Ring Style |
| 00818613027327 | 15mm Distractor |
| 00818613027310 | 14mm Distractor |
| 00818613027303 | 13mm Distractor |
| 00818613027297 | 12mm Distractor |
| 00818613027280 | 11mm Distractor |
| 00818613027273 | 10mm Distractor |
| 00818613027266 | 9mm Distractor |
| 00818613027259 | 8mm Distractor |
| 00818613027242 | 7mm Distractor |
| 00818613021547 | Lateral Curette, Ring Size #3 Up Angled Curette, Ring Size #3 |
| 00818613021530 | Straight Curette, Ring Size #3 Up Angled Curette, Ring Size #3 |
| 00818613021523 | Down Pushing Curette Up Angled Curette, Ring Size #3 |
| 00818613021516 | Up Angled Curette, Ring Size #3 Up Angled Curette, Ring Size #3 |
| 00818613021455 | VS Bone Funnel |
| 00818613021448 | VS Bone Tamp |
| 00818613021257 | Tall Obturator Impactor |
| 00818613021240 | Short Obturator Impactor |
| 00818613021172 | Implant Tamp |
| 00818613021141 | 16cm Offset Graft Guide |
| 00818613021134 | 16cm Straight Graft Guide |
| 00818613021066 | Straight Rasp |
| 00818613021059 | 30 Degree Bent Rasp |
| 00818613021035 | Tall Cannula |
| 00818613021028 | Short Cannula |
| 00818613021011 | 3.25mm Rasp |
| 00818613020946 | CMP-00043 GB Impactor |
| 00818613020922 | CMP-00023 GB Cannula Tall |
| 00818613020915 | GB Cannula Short |
| 00818613020908 | CMP-00021 GB Dilator 2, Tall |
| 00818613020892 | CMP-00020 GB Dilator 2, Short |
| 00818613020885 | GB Dilator 1 |
| 00818613020878 | Shaver, 14mm |
| 00818613020861 | Shaver, 13mm |
| 00818613020854 | Shaver, 12mm |
| 00818613020847 | Shaver, 11mm |
| 00818613020830 | Shaver, 10mm |
| 00818613020823 | Shaver, 9mm |
| 00818613020816 | Shaver, 8mm |
| 00818613020809 | Shaver, 7mm |
| 00818613020601 | Split Shim Removal Tool |
| 00818613020502 | CR 9.5MM ANGLED UTERINE CURETTE (Ring Curette) |
| 00818613020496 | Distractor size 14mm |
| 00818613020489 | Distractor size 13mm |
| 00818613020472 | Distractor size 12mm |
| 00818613020465 | Distractor size 11mm |