| Primary Device ID | 00810045534473 |
| NIH Device Record Key | c9c0d8f2-fdc3-45e8-9df7-55a7d7decdb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accelus Navigated Reusable Instruments |
| Version Model Number | ASY-00730 |
| Catalog Number | ASY-00730 |
| Company DUNS | 080300717 |
| Company Name | INTEGRITY IMPLANTS INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | 00810045534473 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
[00810045534473]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-14 |
| Device Publish Date | 2022-03-04 |
| 00840200404174 | 4.0mm Cannulated Dual Lead Nav Tap |
| 00840200404143 | Nav Probe Duck Billed Straight |
| 00840200404099 | Nav Probe Straight |
| 00840200404082 | Nav Bone Awl |
| 00840200404075 | 5.5-6.0mm Polyaxial Nav Screw Driver |
| 00810045535043 | Nav 4.0mm Dual Lead Tap |
| 00810045535036 | Nav 8.5mm Cannulated Dual Lead Tap |
| 00810045535029 | Nav 7.5mm Cannulated Dual Lead Tap |
| 00810045535012 | Nav 6.5mm Cannulated Dual Lead Tap |
| 00810045535005 | Nav 5.5mm Cannulated Dual Lead Tap |
| 00810045534992 | Nav 5.0mm Cannulated Dual Lead Tap |
| 00810045534985 | Nav 4.5mm Cannulated Dual Lead Tap |
| 00810045534978 | Nav 8.5 mm Quad Lead Tap |
| 00810045534961 | Nav 7.5 mm Quad Lead Tap |
| 00810045534954 | Nav 6.5 mm Quad Lead Tap |
| 00810045534947 | Nav 5.5 mm Quad Lead Tap |
| 00810045534930 | Nav 5.0 mm Quad Lead Tap |
| 00810045534923 | Nav 4.5 mm Quad Lead Tap |
| 00810045534916 | Nav 4.0 mm Quad Lead Tap |
| 00810045534558 | Nav 4.5mm Dual Lead Tap |
| 00810045534541 | Nav 5.0mm Dual Lead Tap |
| 00810045534534 | Nav 5.5mm Dual Lead Tap |
| 00810045534527 | Nav 6.5mm Dual Lead Tap |
| 00810045534510 | Nav 7.5mm Dual Lead Tap |
| 00810045534503 | Nav 8.5mm Dual Lead Tap |
| 00810045534497 | Nav 9.5mm Dual Lead Tap |
| 00810045534480 | Nav 10.5mm Dual Lead Tap |
| 00810045534473 | Nav Modular Shank Driver - SM Ball |
| 00810045534466 | 5.5-6.0mm Polyaxial MG Nav Screw Driver |