DEVICE: ZyMot (00860451001212)
Device Identifier (DI) Information
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 |
|---|---|
| MQK | Labware, Assisted Reproduction |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K173075 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
89abb796-4c29-4a42-b13d-3ae313574b8e
March 05, 2021
1
February 25, 2021
March 05, 2021
1
February 25, 2021
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:
00860451001243
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined