Primary Device ID | 00191506049188 |
NIH Device Record Key | 2e46de3f-e607-48c1-826b-0903fe50cbf9 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | M00505550 |
Catalog Number | M00505550 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00191506049188 [Primary] |
OCW | Endoscopic tissue approximation device |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-25 |
Device Publish Date | 2025-02-17 |
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 - NA | 2025-02-25Suture Cinch - Long |
00191506049188 - NA | 2025-02-25 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 System | 2025-01-23 Pre-Loaded Torqueable Microcatheter |
08714729269915 - Electrophysiology Cable | 2025-01-15 Sterile Cable |