KOU-7

GUDID 04058749027990

CERAMO RONDO micro needle holder, with lock, cvd. 2.0x210mm

Fehling Instruments GmbH & Co. KG

Suturing needle holder, reusable
Primary Device ID04058749027990
NIH Device Record Key9456e6d9-4eaa-4daa-b1b5-ae16cfc27b9e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKOU-7
Catalog NumberKOU-7
Company DUNS315028238
Company NameFehling Instruments GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com
Phone800 334-5464
Emailinfo@fehlingsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104058749027990 [Primary]

FDA Product Code

HXKHolder, Needle; Orthopedic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


[04058749027990]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

Devices Manufactured by Fehling Instruments GmbH & Co. KG

04058749002157 - NA2026-02-05 CERAMO PLANO-S non-traum.micro forceps, bayo.,1.2x225mm
04058749007978 - NA2026-02-05 CERAMO PLANO micro vessel scissors, 25°ang.100 mm,blade 7mm
04058749008029 - NA2026-02-05 CERAMO PLANO micro vessel scissors, 60°ang.100 mm,blade 7mm
04058749008067 - NA2026-02-05 CERAMO PLANO micro vessel scissors, 90°ang.100 mm,blade 7mm
04058749008913 - NA2026-02-05 CERAMO PLANO-S micro scissors bayo., delicate, straight, 225mm
04058749009927 - NA2026-02-05 CERAMO TC RONDO micro vessel scissors, angl. 125°, 250 mm
04058749013283 - NA2026-02-05 CERAMO PLANO non-traumatic micro forceps, 1.2 x 210 mm
04058749027990 - NA2026-02-05CERAMO RONDO micro needle holder, with lock, cvd. 2.0x210mm
04058749027990 - NA2026-02-05 CERAMO RONDO micro needle holder, with lock, cvd. 2.0x210mm

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.