DEVICE: A.M.I.-dock Applicator Standard 5mm (AMIA054910)
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Device Identifier (DI) Information
A.M.I.-dock Applicator Standard 5mm
A05 491
Not in Commercial Distribution
A05 491
AMI Agency for Medical Innovations GmbH
A05 491
Not in Commercial Distribution
A05 491
AMI Agency for Medical Innovations GmbH
Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm.
The A.M.I.-dock Applicator serves as endoscopic carrier for the A.M.I.-dock Disposable Loading Units (DLU).
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 63868 | Laparoscopic surgery handle |
A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GDO | Applier, Surgical, Clip |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 510 Millimeter |
| Outer Diameter: 5 Millimeter |
Device Record Status
88de53ec-b384-473e-9d70-f48eac96d1a5
October 04, 2022
3
November 28, 2018
October 04, 2022
3
November 28, 2018
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