DEVICE: Edwards eSheath+ Introducer set (00690103215472)

Device Identifier (DI) Information

Edwards eSheath+ Introducer set
916ESP
In Commercial Distribution
916ESPA
Edwards Lifesciences LLC
00690103215472
GS1

1
134139174 *Terms of Use
Edwards eSheath+ Introducer set
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DYB Introducer, Catheter
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K200258 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Sore in a cool, dry place
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 16F Sheath Inner Diameter
CLOSE

Device Record Status

229da540-2920-43bc-8b65-8e79036eb08d
September 30, 2024
4
October 06, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
CLOSE