HANAROSTENT® Biliary (NNN)
GUDID 08806367017383
Un-covered self-expanding nitinol biliary stent
M.I.Tech Co., Ltd.
Bare-metal biliary stent| Primary Device ID | 08806367017383 |
| NIH Device Record Key | a04a344a-3747-4304-8d88-7b53d2a24fc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HANAROSTENT® Biliary (NNN) |
| Version Model Number | SHS-10-040-060 |
| Company DUNS | 688454359 |
| Company Name | M.I.Tech Co., Ltd. |
| 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 | true |
| Manufacturing Date | true |
| 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
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr | |
| Phone | +827043047450 |
| inae116@mitech.co.kr |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 40 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806367017383 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111149
FDA Product Code
| FGE | Catheter, Biliary, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-04-08 |
| Device Publish Date | 2017-07-03 |
On-Brand Devices [HANAROSTENT® Biliary (NNN)]
| 08806367047199 | Un-covered self-expanding nitinol biliary stent |
| 08806367047182 | Un-covered self-expanding nitinol biliary stent |
| 08806367047151 | Un-covered self-expanding nitinol biliary stent |
| 08806367047144 | Un-covered self-expanding nitinol biliary stent |
| 08806367047137 | Un-covered self-expanding nitinol biliary stent |
| 08806367047120 | Un-covered self-expanding nitinol biliary stent |
| 08806367047113 | Un-covered self-expanding nitinol biliary stent |
| 08806367047106 | Un-covered self-expanding nitinol biliary stent |
| 08806367047090 | Un-covered self-expanding nitinol biliary stent |
| 08806367047083 | Un-covered self-expanding nitinol biliary stent |
| 08806367047076 | Un-covered self-expanding nitinol biliary stent |
| 08806367047069 | Un-covered self-expanding nitinol biliary stent |
| 08806367047052 | Un-covered self-expanding nitinol biliary stent |
| 08806367047045 | Un-covered self-expanding nitinol biliary stent |
| 08806367047038 | Un-covered self-expanding nitinol biliary stent |
| 08806367047021 | Un-covered self-expanding nitinol biliary stent |
| 08806367017642 | Un-covered self-expanding nitinol biliary stent |
| 08806367017628 | Un-covered self-expanding nitinol biliary stent |
| 08806367017611 | Un-covered self-expanding nitinol biliary stent |
| 08806367017604 | Un-covered self-expanding nitinol biliary stent |
| 08806367017598 | Un-covered self-expanding nitinol biliary stent |
| 08806367017581 | Un-covered self-expanding nitinol biliary stent |
| 08806367017574 | Un-covered self-expanding nitinol biliary stent |
| 08806367017567 | Un-covered self-expanding nitinol biliary stent |
| 08806367017468 | Un-covered self-expanding nitinol biliary stent |
| 08806367017444 | Un-covered self-expanding nitinol biliary stent |
| 08806367017437 | Un-covered self-expanding nitinol biliary stent |
| 08806367017420 | Un-covered self-expanding nitinol biliary stent |
| 08806367017413 | Un-covered self-expanding nitinol biliary stent |
| 08806367017406 | Un-covered self-expanding nitinol biliary stent |
| 08806367017390 | Un-covered self-expanding nitinol biliary stent |
| 08806367017383 | Un-covered self-expanding nitinol biliary stent |
Trademark Results [HANAROSTENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HANAROSTENT 79343425 not registered Live/Pending |
M.I.Tech Co.,Inc 2022-05-31 |
 HANAROSTENT 79078614 3903217 Live/Registered |
M.I.Tech Co.,Inc 2009-09-22 |
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