Primary Device ID | 00191506055769 |
NIH Device Record Key | 7b6f95ee-ffc2-46da-918b-93e91e76fe28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IceSphere™ |
Version Model Number | H7493968435730 |
Catalog Number | H7493968435730 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Length | 175 Millimeter |
Needle Gauge | 17 Gauge |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00191506055769 [Primary] |
GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-27 |
Device Publish Date | 2025-02-19 |
00191506046330 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046347 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046354 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046361 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046378 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046385 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046392 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
00191506046408 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ICESPHERE 77431013 3562388 Live/Registered |
Galil Medical Ltd. 2008-03-25 |