M00505550

GUDID 00191506049188

Suture Cinch - Long

BOSTON SCIENTIFIC CORPORATION

Suture/ligature tightener, single-use
Primary Device ID00191506049188
NIH Device Record Key2e46de3f-e607-48c1-826b-0903fe50cbf9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM00505550
Catalog NumberM00505550
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506049188 [Primary]

FDA Product Code

OCWEndoscopic tissue approximation device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-25
Device Publish Date2025-02-17

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00191506060138 - OverStitch™2025-02-25 Polypropylene Suture
00191506049157 - X-Tack™2025-02-25 Endoscopic HeliX Tacking System (Gastric)
00191506049164 - X-Tack™2025-02-25 Endoscopic HeliX Tacking System (Colonic)
00191506049188 - NA2025-02-25Suture Cinch - Long
00191506049188 - NA2025-02-25 Suture Cinch - Long
00191506060046 - OverStitch™2025-02-25 Suture Cinch
08714729269779 - Polaris X™2025-02-04 Catheter Cable, Sterile Cable
08714729839835 - Direxion™ HI-FLO™ Transend™-18 System2025-01-23 Pre-Loaded Torqueable Microcatheter
08714729269915 - Electrophysiology Cable2025-01-15 Sterile Cable

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.