TissueTak™ AR-19021TT-1
GUDID 07290017155364
TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator Cuff Augmentation Kit
VIA SURGICAL LTD
Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable| Primary Device ID | 07290017155364 |
| NIH Device Record Key | cdcb4247-6489-47ee-8ffa-2756ccedda75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueTak™ |
| Version Model Number | AR-19021TT-1 |
| Catalog Number | AR-19021TT-1 |
| Company DUNS | 600319250 |
| Company Name | VIA SURGICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 20.9 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017155364 [Primary] |
| GS1 | 17290017155361 [Package] Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203117
FDA Product Code
| GDW | Staple, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-09 |
| Device Publish Date | 2021-12-01 |
On-Brand Devices [TissueTak™]
| 17290017155347 | Non-Sterile Sample of the TissueTak™ Absorbable - 10 Absorbable Fasteners Not for Human Use |
| 17290017155309 | TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners |
| 07290017155357 | Non-Sterile Sample of the TissueTak™ Permanent - 10 Permanent Fasteners Not for Human Use |
| 07290017155364 | TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator |
Trademark Results [TissueTak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUETAK 90005046 not registered Live/Pending |
Arthrex, Inc. 2020-06-16 |
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