Comfort Drain Grasper

FDA UDI

Class I (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name: Comfort Drain Grasper FDA UDI
Generic Name: Implant handling forceps, tweezers-like FDA UDI
Device Name: 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. FDA UDI
Model / Reference: CDS2010 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: CDS2010 FDA UDI
Primary DI / UDI-DI: EAMICDS20100 FDA UDI
FDA Product Code: GBN FDA UDI
GMDN Term: Implant handling forceps, tweezers-like FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Weight — 21 Gram FDA UDI
Width — 17 Micrometer FDA UDI
Length — 130.5 Millimeter FDA UDI

Category: Implant handling forceps, tweezers-like

Comfort Drain Grasper by AMI Agency for Medical Innovations GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implant handling forceps, tweezers-like.

Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: AMI Agency for Medical Innovations GmbH

Sources (1)

FDA UDI 12d89bf9-e535-422c-8f4a-f967e475da20 35 fields · synced Jun 1, 2026