DEVICE: Endoch (EAI0809)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Endoch
EAI-0809
In Commercial Distribution
EAI-0809
Endoch Inc
EAI-0809
In Commercial Distribution
EAI-0809
Endoch Inc
DISPOSABLE LAPAROSCOPIC METZENBAUM SCISSORS, STRAIGHT, HEAVY BLADES, PATTERN
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 63163 | Rigid endoscopic scissors, single-use |
A sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| JOK | Scissors, Medical, Disposable |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K171825 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ea695316-84d1-4f10-b548-3b77c79da693
June 10, 2019
1
June 01, 2019
June 10, 2019
1
June 01, 2019
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined