| Primary Device ID | M27217185C121 |
| NIH Device Record Key | 12ab34d7-5281-42eb-860b-26d01e1133bf |
| Commercial Distribution Discontinuation | 2023-12-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Integra® |
| Version Model Number | 17185C12 |
| Company DUNS | 531408342 |
| Company Name | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL DRY PLACE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780034711 [Primary] |
| HIBCC | M27217185C121 [Secondary] |
| IKD | CABLE, ELECTRODE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
[M27217185C121]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-03-18 |
| Device Publish Date | 2016-08-12 |
| M272EDSEP1 | The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cort |
| M27240M081 | The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cort |
| M272EDSCF1 | The electrode connecting cable EDSCF is a reusable device used to connect the Integra® Sphenoid |
| M272ECCFS641 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS481 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS321 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS241 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS021 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M721 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M641 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M581 | The T-shaped female electrode connecting cable is a reusable device used to connect the Integra |
| M27240M571 | The T-shaped female electrode connecting cable is a reusable device used to connect the Integra |
| M27240M561 | The T-shaped female electrode connecting cable is a reusable device used to connect the Integra |
| M27240M551 | The T-shaped female electrode connecting cable is a reusable device used to connect the Integra |
| M27240M441 | The T-shaped female electrode connecting cable is a reusable device used to connect the Integra |
| M27240M401 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M391 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M381 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M371 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M361 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M351 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M341 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M331 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M27240M321 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M2729101261 | The Intracranial Pressure Monitoring Cup Catheter (85 cm) acts as a hydrostatic coupler that can |
| M2729101251 | The Intracranial Pressure Monitoring Cup Catheter (100 cm) acts as a hydrostatic coupler that ca |
| 30381780035507 | The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a fou |
| M272OCS2PND1 | The OCS2PND is a bipolar stimulating probe for cortical stimulation with malleable tips for prec |
| M2729MD2701 | The Integra Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in |
| M2729012241 | The Integra 61 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h |
| M2729012181 | The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h |
| M2729012121 | The Integra 31 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h |
| 30381780034425 | The 31 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap |
| 30381780034418 | The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable h |
| 30381780034395 | The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable h |
| 30381780033206 | The 61 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap |
| 30381780033176 | The 46 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap |
| 30381780023719 | The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a fou |
| M272PS2P1 | The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for |
| M272ECCFS201 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS161 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS121 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS101 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS081 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS061 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCFS041 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCF81 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCF64161 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCF641 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |
| M272ECCF61 | The female electrode connecting cable is a reusable device used to connect the Integra® Cortica |