AccessGUDID - DEVICE: Comfort Drain Grasper (EAMICDS20100)

GUDID

Device Identifier (DI) Information

Brand Name: Comfort Drain Grasper
Version or Model: CDS2010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CDS2010
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMICDS20100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect the coupling piece with the cut / trimmed drain during the implantation of a Comfort Drain.

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?
62996	Implant handling forceps, tweezers-like	A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on tissues and is not a dedicated tissue clip applier. It has a tweezers-like design (may be a micro/fine instrument) whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of metal, available in various sizes/designs, and is commonly dedicated to a proprietary implant. This is a reusable device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GBN	Catheter, Pediatric, General & Plastic Surgery

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
Weight: 21 Gram
Width: 17 Micrometer
Length: 130.5 Millimeter

Device Record Status

Public Device Record Key: 12d89bf9-e535-422c-8f4a-f967e475da20
Public Version Date: December 31, 2018
Public Version Number: 1
DI Record Publish Date: November 29, 2018