| Primary Device ID | 81195401237348 |
| NIH Device Record Key | 987e9a76-738c-4adb-a6d8-4884f250ec55 |
| Commercial Distribution Discontinuation | 2016-12-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | 8mm Angled Curette |
| Version Model Number | 6189-03 |
| Catalog Number | 6189-03 |
| Company DUNS | 017663522 |
| Company Name | INTERVENTIONAL SPINE, 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 |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com | |
| Phone | 800-497-0484 |
| www.cs@i-spineinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 81195401237348 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[81195401237348]
Moist Heat or Steam Sterilization
[81195401237348]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2015-09-21 |
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| 81195401107962 - Opticage Expandable Interbody Implant | 2020-02-24 9mm Width x 26mm Length by 9mm-14mm Expandable Height |
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| 81195401109393 - Opticage Expandable Interbody Implant | 2020-02-24 10mm Width x 21mm Length by 9mm-14mm Expandable Height |
| 81195401110900 - Opticage Expandable Interbody Implant | 2020-02-24 10mm Width x 26mm Length by 9mm-14mm Expandable Height |
| 81195401111686 - Opticage Expandable Interbody Implant | 2020-02-24 10mm Width x 30mm Length by 9mm-14mm Expandable Height |
| 81195401112362 - Opticage Expandable Interbody Implant | 2020-02-24 11mm Width x 21mm Length by 9mm-14mm Expandable Height |