AccessGUDID - DEVICE: A.M.I.-dock Applicator Short 10mm (EAMIA101120)

GUDID

Device Identifier (DI) Information

Brand Name: A.M.I.-dock Applicator Short 10mm
Version or Model: A10 112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A10 112
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIA101120
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 392 Millimeter
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: 4d27ec75-4f04-4a33-95a3-a1251ba4389b
Public Version Date: October 04, 2022
Public Version Number: 3
DI Record Publish Date: November 28, 2018