DEVICE: RI Pipettes (05060170181881)
Device Identifier (DI) Information
RI Pipettes
ICSI-Plus Spiked Injection
In Commercial Distribution
7-71-4SI00/20
RESEARCH INSTRUMENTS LIMITED
ICSI-Plus Spiked Injection
In Commercial Distribution
7-71-4SI00/20
RESEARCH INSTRUMENTS LIMITED
Assisted Reproduction Microtools (Pipettes)
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? |
---|---|---|---|---|
46553 | Assisted reproduction microtool |
A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQH | MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K991261 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 4 Micrometer |
Device Record Status
6d4833e6-00f4-47db-aa16-d2a6ccdf5cee
February 28, 2024
4
September 17, 2016
February 28, 2024
4
September 17, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05060170187227
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
4546790202
origio@origio.com
origio@origio.com