G-ARMOR STENT® 614738
GUDID 04046955767243
G ARMOR GCM016 5.2CM 24MM 5.5CM 16F
B BRAUN INTERVENTIONAL SYSTEMS, INC
Bare-metal aortic stent| Primary Device ID | 04046955767243 |
| NIH Device Record Key | 37651d72-9435-4871-aada-1f40d13de4b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-ARMOR STENT® |
| Version Model Number | 614738 |
| Catalog Number | 614738 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| 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 |
Customer Support Contacts
Device Dimensions
| 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 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046955767243 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P150028
FDA Product Code
| PNF | Aortic stent |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-16 |
| Device Publish Date | 2022-05-07 |
On-Brand Devices [G-ARMOR STENT®]
| 04046955768042 | G ARMOR COVERED GC8Z63 |
| 04046955768035 | G ARMOR COVERED GC8Z57 |
| 04046955768028 | G ARMOR COVERED GC8Z52 |
| 04046955768011 | G ARMOR COVERED GC8Z46 |
| 04046955768004 | G ARMOR COVERED GC10Z63 |
| 04046955767991 | G ARMOR COVERED GC10Z57 |
| 04046955767984 | G ARMOR COVERED GC10Z52 |
| 04046955767977 | G ARMOR COVERED GC10Z46 |
| 04046955767960 | G ARMOR GM044 6.3CM 30MM 6.5CM 16F |
| 04046955767953 | G ARMOR GM043 6.3CM 28MM 6.5CM 16F |
| 04046955767946 | G ARMOR GM042 6.3CM 26MM 6.5CM 16F |
| 04046955767939 | G ARMOR GM041 5.7CM 30MM 6CM 16F |
| 04046955767922 | G ARMOR GM040 5.7CM 28MM 6CM 16F |
| 04046955767915 | G ARMOR GM039 5.7CM 26MM 6CM 16F |
| 04046955767908 | G ARMOR GM038 5.2CM 30MM 5.5CM 16F |
| 04046955767892 | G ARMOR GM037 5.2CM 28MM 5.5CM 16F |
| 04046955767885 | G ARMOR GM036 5.2CM 26MM 5.5CM 16F |
| 04046955767878 | G ARMOR GM035 4.6CM 30MM 5CM 16F |
| 04046955767861 | G ARMOR GM034 4.6CM 28MM 5CM 16F |
| 04046955767854 | G ARMOR GM033 4.6CM 26MM 5CM 16F |
| 04046955767847 | G ARMOR GM032 6.3CM 24MM 6.5CM 14F |
| 04046955767830 | G ARMOR GM031 6.3CM 22MM 6.5CM 14F |
| 04046955767823 | G ARMOR GM030 6.3CM 20MM 6.5CM 14F |
| 04046955767816 | G ARMOR GM029 6.3CM 18MM 6.5CM 14F |
| 04046955767809 | G ARMOR GM028 6.3CM 16MM 6.5CM 14F |
| 04046955767793 | G ARMOR GM027 6.3CM 15MM 6.5CM 13F |
| 04046955767786 | G ARMOR GM026 6.3CM 14MM 6.5CM 13F |
| 04046955767779 | G ARMOR GM025 6.3CM 12MM 6.5CM 13F |
| 04046955767762 | G ARMOR GM024 5.7CM 24MM 6CM 14F |
| 04046955767755 | G ARMOR GM023 5.7CM 22MM 6CM 14F |
| 04046955767748 | G ARMOR GM022 5.7CM 20MM 6CM 14F |
| 04046955767731 | G ARMOR GM021 5.7CM 18MM 6CM 14F |
| 04046955767724 | G ARMOR GM020 5.7CM 16MM 6CM 14F |
| 04046955767717 | G ARMOR GM019 5.7CM 15MM 6CM 13F |
| 04046955767700 | G ARMOR GM018 5.7CM 14MM 6CM 13F |
| 04046955767694 | G ARMOR GM017 5.7CM 12MM 6CM 13F |
| 04046955767687 | G ARMOR GM016 5.2CM 24MM 5.5CM 14F |
| 04046955767670 | G ARMOR GM015 5.2CM 22MM 5.5CM 14F |
| 04046955767663 | G ARMOR GM014 5.2CM 20MM 5.5CM 14F |
| 04046955767656 | G ARMOR GM013 5.2CM 18MM 5.5CM 14F |
| 04046955767649 | G ARMOR GM012 5.2CM 16MM 5.5CM 14F |
| 04046955767632 | G ARMOR GM011 5.2CM 15MM 5.5CM 13F |
| 04046955767625 | G ARMOR GM010 5.2CM 14MM 5.5CM 13F |
| 04046955767618 | G ARMOR GM009 5.2CM 12MM 5.5CM 13F |
| 04046955767601 | G ARMOR GM008 4.6CM 24MM 5CM 14F |
| 04046955767595 | G ARMOR GM007 4.6CM 22MM 5CM 14F |
| 04046955767588 | G ARMOR GM006 4.6CM 20MM 5CM 14F |
| 04046955767571 | G ARMOR GM005 4.6CM 18MM 5CM 14F |
| 04046955767564 | G ARMOR GM004 4.6CM 16MM 5CM 14F |
| 04046955767557 | G ARMOR GM003 4.6CM 15MM 5CM 13F |
Trademark Results [G-ARMOR STENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-ARMOR STENT 90495603 not registered Live/Pending |
NUMED, INC. 2021-01-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.