DEVICE: NA (00815634020313)
Device Identifier (DI) Information
NA
0600127
In Commercial Distribution
Micromedics, Inc.
0600127
In Commercial Distribution
Micromedics, Inc.
2-Part Endoscopic Applicator with Malleable Tip
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 58451 | Fibrin sealant biochemical preparation/application kit, endoscopic |
A collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, seal air leaks, adhere tissues). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including an endoscopic applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the fibrin sealant. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GCJ | Laparoscope, General & Plastic Surgery |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K123847 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2f75452c-4ba2-4445-947a-9390354b6ee0
April 25, 2023
4
September 25, 2016
April 25, 2023
4
September 25, 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 |
|---|---|---|---|---|---|
| 10815634020310 | 6 | 00815634020313 | In Commercial Distribution | SHELFL BOX | |
| 20815634020317 | 1 | 10815634020310 | In Commercial Distribution | SHIP BOX |
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