AccessGUDID - DEVICE: A.M.I.-dock Bluntdissect DLU 10mm (EAMIA101310)

GUDID

Device Identifier (DI) Information

Brand Name: A.M.I.-dock Bluntdissect DLU 10mm
Version or Model: A10 131
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A10 131
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIA101310
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.

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:	Yes
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?
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 28 Millimeter
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: e05a9fd9-9cd5-45e9-a16e-6a2c4a805b63
Public Version Date: October 04, 2022
Public Version Number: 2
DI Record Publish Date: November 28, 2018