409903730US

GUDID 00814334022771

BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, for extraction of bony structures, in endoscopic spine surgery, Sterile, for single use

Richard Wolf GmbH

Orthopaedic bur, single-use
Primary Device ID00814334022771
NIH Device Record Keyb656045d-dec6-465d-8c1e-35cf88d713ae
Commercial Distribution StatusIn Commercial Distribution
Version Model Number409903730US
Catalog Number409903730US
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter
Outer Diameter3 Millimeter
Length350 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100814334022764 [Primary]
GS100814334022771 [Unit of Use]

FDA Product Code

HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-21
Device Publish Date2022-12-27

Devices Manufactured by Richard Wolf GmbH

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00814334022771 - NA2024-11-21BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, for extraction of bony structures, in endoscopic spine surgery, Sterile, for single use
00814334022771 - NA2024-11-21 BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, for extra
00814334022795 - NA2024-11-21 DIAMOND BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, f
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04055207016138 - NA2024-11-21 NEEDLE HOLDER INSERT WITH SHEATH Ø 5MM straight with carbide insert, WL 320mm, with irrigation connection, reusable
04055207016572 - NA2024-11-21 NEEDLE HOLDER INSERT WITH SHEATH Ø 5MM straight with carbide insert, WL 410mm, with irrigation connection, reusable
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