DEVICE: GLIDESHEATH SLENDER (04987350723048)
Device Identifier (DI) Information
GLIDESHEATH SLENDER
RM*ES7J10HAT
Not in Commercial Distribution
RM*ES7J10HAT
TERUMO CORPORATION
RM*ES7J10HAT
Not in Commercial Distribution
RM*ES7J10HAT
TERUMO CORPORATION
GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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.
|
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: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 11. |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 2.45 Millimeter |
Length: 10 Centimeter |
Device Size Text, specify: Those Clinically Relevant Size are relative to the sheath. |
Device Record Status
00bd21a6-b8cd-4e1e-97fd-f63d827fbd20
March 20, 2024
5
September 09, 2016
March 20, 2024
5
September 09, 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 |
---|---|---|---|---|---|
34987350723049 | 5 | 04987350723048 | 2018-07-31 | Not in Commercial Distribution | Shelfbox |
54987350723043 | 4 | 34987350723049 | 2018-07-31 | Not 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