FDA.reportPublic FDA data

TissueTak™

Primary DI
17290017155347
Brand
TissueTak™
Company
VIA SURGICAL LTD
Model
AS-19021TT
Catalog number
AS-19021TT
Device description
Non-Sterile Sample of the TissueTak™ Absorbable - 10 Absorbable Fasteners Not for Human Use
Published
2021-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203117000TissueTak deviceVia Surgical , Ltd.2021-01-07GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017155347PackageGS15In Commercial Distribution
07290017155340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001715534717290017155347
07290017155340072900171553407290017155340

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, bioabsorbableA bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20.9Centimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600319250
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017155012FasTouch™SFTP25SFTP252017-08-29
07290017155210FasTouch™ AbsorbableFTA25FTA252019-09-14
07290017155241FasTouch™ AbsorbableSFTA25SFTA252019-09-14
07290017155272FasTouch™ AbsorbableFTAC10FTAC102019-09-14
07290017155289FasTouch™ AbsorbableSFTAC10SFTAC102019-09-14
07290017155302TissueTak™AR-19021TTAR-19021TT2021-02-04
07290017155340TissueTak™AS-19021TTAS-19021TT2021-02-04
07290017155364TissueTak™AR-19021TT-1AR-19021TT-12021-12-01
07290017155357TissueTak™AS-19022TTAS-19022TT2021-03-04
07290017155104FasTouch™FTP25FTP252017-08-21
17290017155309TissueTak™AR-19021TTAR-19021TT2021-02-04
17290017155019FasTouch™SFTP25SFTP252017-08-29
17290017155217FasTouch™ AbsorbableFTA25FTA252019-09-14
17290017155248FasTouch™ AbsorbableSFTA25SFTA252019-09-14
17290017155279FasTouch™ AbsorbableFTAC10FTAC102019-09-14
17290017155286FasTouch™ AbsorbableSFTAC10SFTAC102019-09-14
07290017155043FasTouch™SFTPC10SFTPC102017-08-29
07290017155111FasTouch™FTPC10FTPC102017-08-21
17290017155040FasTouch™SFTPC10SFTPC102017-08-29
17290017155118FasTouch™FTPC10FTPC102017-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27