Primary Device ID | 00191506060107 |
NIH Device Record Key | d043efe9-50b4-44e6-8a95-6a495a5e4e94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OverStitch NXT ™ |
Version Model Number | M00505430 |
Catalog Number | M00505430 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | 00191506060107 [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 | 2025-08-05 |
Device Publish Date | 2025-07-28 |
00191506049379 - OverTube™ | 2025-08-05 Endoscopic Access System |
00191506060053 - Tissue Helix | 2025-08-05 Tissue HeliX Pro |
00191506060060 - NXT Tissue HeliX Pro | 2025-08-05 Intragastric Balloon System |
00191506060107 - OverStitch NXT ™ | 2025-08-05Intragastric Balloon System |
00191506060107 - OverStitch NXT ™ | 2025-08-05 Intragastric Balloon System |
08714729144182 - Optiflo | 2025-07-17 Hemostasis Catheter |
08714729145264 - Optiflo | 2025-07-17 Hemostasis Catheter |
08714729874805 - LithoVue | 2025-07-08 Single-Use Digital Flexible Ureteroscope |
08714729874812 - LithoVue | 2025-07-08 Single-Use Digital Flexible Ureteroscope |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OVERSTITCH NXT 97540943 not registered Live/Pending |
APOLLO ENDOSURGERY US, INC. 2022-08-09 |