DEVICE: Endoch (EAI0817)

Device Identifier (DI) Information

Endoch
EAI-0817
In Commercial Distribution
EAI-0817
Endoch Inc
EAI0817
HIBCC

1
241382683 *Terms of Use
DISPOSABLE LAPAROSCOPIC MICRO SCISSORS, CURVED
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
63613 Invasive blood pressure monitoring damping device
A small, sterile, non-powered device intended to be placed between external components of an invasive blood pressure monitoring tubing set (e.g., between intra-arterial line and transducer) to improve the accuracy of the pressure measurement. It is in the form of a connector with an additional section containing an air chamber and diaphragm. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
JOK Scissors, Medical, Disposable
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K171825 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

53be6a04-b694-47b2-8e03-ac133abd91ec
June 10, 2019
1
June 01, 2019
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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE