DEVICE: GLIDESHEATH (00389701011288)
Device Identifier (DI) Information
GLIDESHEATH
35-1660
In Commercial Distribution
35-1660
TERUMO MEDICAL CORPORATION
35-1660
In Commercial Distribution
35-1660
TERUMO MEDICAL CORPORATION
GLIDESHEATH 0.035" Dilator Hydrophilic Coated Introducer Sheath
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58865 | Vascular catheter introduction set, nonimplantable |
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not store at extreme temperature and humidity |
Special Storage Condition, Specify: Avoid direct sunlight. Keep Dry. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 16 Centimeter |
Device Size Text, specify: Guidewire: 0.035 Inch x 80 Centimeter Stainless Steel with Flexible J-Tip |
Catheter Gauge: 6 French |
Device Size Text, specify: Guidewire Compatibility: 0.035 Inch |
Device Record Status
d708593c-5962-4640-9991-fa1696cf8d3c
March 20, 2024
4
September 24, 2016
March 20, 2024
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30389701011289 | 5 | 00389701011288 | In Commercial Distribution | Shelfbox | |
50389701011283 | 10 | 30389701011289 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com