FDA.reportPublic FDA data

Comfort Drain Grasper

Primary DI
EAMICDS20100
Brand
Comfort Drain Grasper
Company
AMI Agency for Medical Innovations GmbH
Model
CDS2010
Catalog number
CDS2010
Device description
For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect the couplingpiece with the cut / trimmed drain during the implantation of a Comfort Drain.
Published
2018-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GBNCatheter, Pediatric, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBNCatheter, Pediatric, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAMICDS20100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Implant handling forceps, tweezers-likeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130.5Millimeter
Weight21Gram
Width17Micrometer

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303655286
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EAMIRAR20810RAR Flexi ProbeRAR2081RAR20812018-11-28
EAMIICT50100i-Cut Power SupplyICT50102025-05-05
EAMIICT50110i-CutICT5011ICT50112025-05-05
EAMIICT50500i-Cut Power Supply Type AICT50502025-05-05
EAMIECI10310A.M.I. EasyClinch Disposable Tips PremiumECI1031ECI10312019-04-05
EAMIECM10110EasyClinch microECM1011ECM10112019-04-05
EAMIEDI10310A.M.I. EasyDissect Disposable Tips PremiumEDI1031EDI10312019-04-05
EAMIEDI10510A.M.I. EasyHookEDI1051EDI10512019-04-05
EAMIEDM10110EasyDissect microEDM1011EDM10112019-04-05
EAMIESI11310A.M.I. EasyShear Disposable Tips PremiumESI1131ESI11312019-04-05
EAMIESI11510A.M.I. EasyShear Mini Disposable Tips PremiumESI1151ESI11512019-04-05
EAMIESI12100Soft InsertsESI1210ESI12102019-04-05
EAMIESM10110EasyShears microESM1011ESM10112019-04-05
EAMIEVI10110ViperEVI1011EVI10112019-04-05
EAMIEAH10100EasyAct HandleEAH1010EAH10102019-04-05
EAMIEAS13100EasyAct 3 SEAS1310EAS13102019-04-05
EAMIEAS13200EasyAct 3 MEAS1320EAS13202019-04-05
EAMIEAS15100EasyAct 5 SEAS1510EAS15102019-04-05
EAMIEAS15200EasyAct 5 MEAS1520EAS15202019-04-05
EAMIEAS15300EasyAct 5 LEAS1530EAS15302019-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850005416026MedDrainARMM INC.GBN2023-06-08
10850005416057MedDrainARMM INC.GBN2023-06-08
10850005416064MedDrainARMM INC.GBN2023-06-08
10850082007971MedDrainARMM INC.GBN2023-06-08
10850082007988MedDrainARMM INC.GBN2023-06-08
00850005416029MedDrainARMM INC.GBN2023-06-08
00850005416050MedDrainARMM INC.GBN2023-06-08
00850005416067MedDrainARMM INC.GBN2023-06-08
00850082007974MedDrainARMM INC.GBN2023-06-08
00850082007981MedDrainARMM INC.GBN2023-06-08
00817213021537NATIONAL HOSPITAL PACKAGINGSurgi-Pak, Inc.GBN2022-12-06
EAMICDS20010Comfort Drain AMI Agency for Medical Innovations GmbHGBN2018-11-28
10850082007865MedDrainARMM INC.GBN2018-11-02
10850082007872MedDrainARMM INC.GBN2018-11-02
10850082007933MedDrainARMM INC.GBN2018-11-02
10850082007940MedDrainARMM INC.GBN2018-11-02
10850082007957MedDrainARMM INC.GBN2018-11-02