Intergard IGKUT0008RS30
GUDID 00384401001218
Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
INTERVASCULAR SAS
Synthetic vascular graft| Primary Device ID | 00384401001218 |
| NIH Device Record Key | f19dfb6f-d9fd-4374-8781-74af517ec770 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intergard |
| Version Model Number | IGKUT0008RS30 |
| Catalog Number | IGKUT0008RS30 |
| Company DUNS | 382174019 |
| Company Name | INTERVASCULAR SAS |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com | |
| Phone | +33442084646 |
| cardiovascular.vics@getinge.com |
Device Dimensions
| Length | 70 Centimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 70 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384401001218 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K983819
FDA Product Code
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-25 |
On-Brand Devices [Intergard]
| 00384401103868 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401103851 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401103844 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401010760 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401010753 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401010746 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401010739 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401010722 | Intergard Woven Aortic Arch Collagen Coated Vascular Graft |
| 00384401007593 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401007586 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401007562 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401007555 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401007340 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401007265 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401006930 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401006459 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401006190 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401006039 | Intergard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401005902 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401005896 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401005889 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401005872 | Intergard Woven Straight Collagen Coated Vascular Graft |
| 00384401004028 | Intergard Knitted Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001614 | Intergard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft |
| 00384401001607 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401001409 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401001393 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401001386 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401001379 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001362 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001355 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401001294 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001270 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001263 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001249 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401001232 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401001225 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001218 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001201 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001195 | Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft |
| 00384401001171 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001164 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001157 | Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft |
| 00384401001102 | Intergard Knitted Axillo-bifemoral Collagen Coated Vascular Graft |
| 00384401001034 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401001027 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401001010 | Intergard Woven Hemabridge Collagen Coated Vascular Graft |
| 00384401000990 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401000983 | Intergard Knitted Straight Collagen Coated Vascular Graft |
| 00384401000976 | Intergard Knitted Straight Collagen Coated Vascular Graft |
Trademark Results [Intergard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERGARD 77645078 3654477 Live/Registered |
INTERGARD DO BRASIL INDUSTRIA E COMERCIO DE ELETRONICOS E MECANICOS LTDA 2009-01-07 |
 INTERGARD 74488462 2173217 Live/Registered |
DATASCOPE CORP. 1994-02-09 |
 INTERGARD 74462938 not registered Dead/Abandoned |
Ciba-Geigy Corporation 1993-11-24 |
 INTERGARD 73650558 1463258 Dead/Cancelled |
CIBA-GEIGY CORPORATION 1987-03-20 |
 INTERGARD 73394847 1289651 Live/Registered |
International Paint Company, Inc. 1982-09-30 |
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