FDA.reportPublic FDA data

TigerPaw Pro Left Atrial Appendage Closure Device

Primary DI
10607567510996
Brand
TigerPaw Pro Left Atrial Appendage Closure Device
Company
DATASCOPE CORP.
Model
35mm
Catalog number
750001099
Device description
Left Atrial Appendage Closure Device 35mm - 7 pin
Published
2020-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567510996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756751099610607567510996

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001660786
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr0684-00-0403-050684-00-0403-052023-03-14
10607567106694Reinforced Introducer Set for Sensation 7Fr0684-00-0403-060684-00-0403-062023-03-14
10607567107943Reinforced Introducer Set for Sensation Plus & Mega 8Fr0684-00-0403-100684-00-0403-102023-03-14
10607567107301MEGA 8Fr. 50cc IAB0684-00-0498-010684-00-0498-012016-09-15
10607567107318MEGA 8Fr. 50cc IAB (with APA)0684-00-0498-020684-00-0498-022016-09-15
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23
10607567107516Catheter Extenders for 50cc IAB’s 0684-00-05260684-00-05262016-09-14
10607567108001MEGA 8Fr. 50cc IAB (with Statlock)0684-00-0296-010684-00-0296-012016-09-15
10607567108018MEGA 8Fr. 50cc IAB (with Statlock & APA)0684-00-0296-020684-00-0296-022016-09-15
10607567108063SENSATION PLUS 7.5Fr. 40cc IAB & Accessories0684-00-0568-010684-00-0568-012016-09-15
10607567108605SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)0684-00-0576-010684-00-0576-012016-09-15
10607567109381Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S0684-00-0576-050684-00-0576-052016-09-15
10607567109411MEGA 8Fr. 50cc IAB (W/O Statlock)0684-00-0296-030684-00-0296-032016-09-15
10607567109428Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock)0684-00-0568-030684-00-0568-032016-09-15
10607567109435Sensation Plus 8Fr. 50cc IAB (W/O Statlock)0684-00-0576-030684-00-0576-032016-09-15
10607567109442Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China)0684-00-0568-050684-00-0568-052016-09-15
10607567109565Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only0684-00-0568-01U0684-00-0568-01U2016-09-15
10607567109619MEGA 8Fr. 50cc IAB with Accessories, US Only0684-00-0296-01U0684-00-0296-01U2016-09-16
10607567109626MEGA 8Fr. 50cc IAB with Accessories (APA), US Only0684-00-0296-02U0684-00-0296-02U2016-09-16
10607567109633Sensation Plus 8Fr. 50cc IAB with Accessories, US Only0684-00-0576-01U0684-00-0576-01U2016-09-15

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