8394.503

GUDID 04055207060575

SARBU NEEDLE HOLDER Ø 5MM BNDL 2 part, SL 430mm

Richard Wolf GmbH

Suturing needle holder, reusable
Primary Device ID04055207060575
NIH Device Record Keyb5e741d2-b92a-4400-bbb2-cdeedcf70585
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8394503
Catalog Number8394.503
Company DUNS315304071
Company NameRichard Wolf GmbH
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207060575 [Primary]

FDA Product Code

FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


[04055207060575]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-21
Device Publish Date2022-11-01

Devices Manufactured by Richard Wolf GmbH

04055207069790 - NA2026-01-22 KERRISON SHEATH W 5MM CURVED 40° for use with Kerrison handle, WL 130 mm, reusable
04055207069806 - NA2026-01-22 KERRISON SHEATH W 2MM CURVED 40° for use with Kerrison handle, WL 130 mm, reusable
04055207069813 - NA2026-01-22 KERRISON SHEATH W 2MM WL 130MM 40° for use with Kerrison handle, reusable
04055207069820 - NA2026-01-22 KERRISON SHEATH W 5MM WL 130MM 40° for use with Kerrison handle, reusable
04055207069837 - NA2026-01-22 KERRISON SHEATH W 2MM WL 130MM 90° for use with Kerrison handle, reusable
04055207069851 - NA2026-01-22 KERRISON SHEATH W 5MM WL 130MM 90° for use with Kerrison handle, reusable
04055207036693 - POWER STICK M5/02025-12-26 MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, control by footswitch, reusable
04055207000328 - NA2025-12-12 FOOT CONTROL ROCKERSWITCH multifunctional foot control rockerswitch (change between operating system white light / operating sy

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