Primary Device ID | 08714729005520 |
NIH Device Record Key | 343e31b5-7b59-4344-9ac9-73a39b5ab9d9 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | M0062601100 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08714729005520 [Primary] |
GCC | Dilator, catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-07-11 |
Device Publish Date | 2016-09-24 |
08714729298151 - NA | 2024-10-17 Connecting Tube with stopcock |
00191506055301 - OPAL HDx™ | 2024-10-16 Mapping System Workstation PC |
00191506055325 - OPAL HDx™ | 2024-10-16 Mapping System Signal Station |
00191506055370 - OPAL HDx™ | 2024-10-16 Mapping System |
08714729848097 - Colpassist | 2024-10-16 Vaginal Positioning Device |
08714729784432 - Percutaneous Tract Kit | 2024-10-11 Percutaneous Tract Kit |
08714729789536 - Lingeman Percutaneous Tract Kit | 2024-10-11 Percutaneous Tract Kit |
08714729010944 - NA | 2024-10-10 Connecting Tube for 3F through 6F Catheters |