DEVICE: RI MSC (05060170180181)

Device Identifier (DI) Information

RI MSC
Migration Sedimenation Chamber
In Commercial Distribution
7-74-501/20
RESEARCH INSTRUMENTS LIMITED
05060170180181
GS1

20
536139413 *Terms of Use
Assisted Reproduction Labware
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sperm filtration system An assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MQK LABWARE, ASSISTED REPRODUCTION
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112413 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from direct sunlight (UV)
Handling Environment Temperature: between 10 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

fde3c935-018b-49aa-809a-ce40b4daf864
July 06, 2018
3
September 17, 2016
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: 05060170183434 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
4546790202
origio@origio.com
CLOSE