Hemapatch HEK75/75P (1)
GUDID 00384401001515
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
Cardiovascular patch, animal-derived| Primary Device ID | 00384401001515 |
| NIH Device Record Key | 48a9134f-6808-4dac-9fad-8ed046102d1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemapatch |
| Version Model Number | HEK75/75P (1) |
| Catalog Number | HEK75/75P (1) |
| 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
Device Dimensions
| Width | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
| Length | 75 Millimeter |
| Width | 75 Millimeter |
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 |
| 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 | 00384401001515 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964625
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 | 2015-09-24 |
On-Brand Devices [Hemapatch]
| 00384401001591 | Hemapatch Knitted Collagen Coated Vascular Patch |
| 00384401001577 | Hemapatch Knitted Collagen Coated Vascular Patch |
| 00384401001560 | Hemapatch Knitted Collagen Coated Vascular Patch |
| 00384401001522 | Hemapatch Knitted Collagen Coated Vascular Patch |
| 00384401001515 | Hemapatch Knitted Collagen Coated Vascular Patch |
Trademark Results [Hemapatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMAPATCH 74520045 not registered Dead/Abandoned |
INTERVASCULAR, INC. 1994-05-02 |
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