85525812

GUDID 04055207065617

LOGIC HD CAMERA HEAD GREEN For fluorescence imaging with ICG dye, Snap-on locking mechanism, 2 chip, integrated lens f = 24mm, 2 programmable camera-head buttons, Activation/deactivation of near-infrared mode

Richard Wolf GmbH

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera
Primary Device ID04055207065617
NIH Device Record Keye70e167c-a6ac-4000-a37b-72004d4f5774
Commercial Distribution StatusIn Commercial Distribution
Version Model Number85525812
Catalog Number85525812
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207065617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

[04055207065617]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

Devices Manufactured by Richard Wolf GmbH

04055207069776 - NA2024-04-09 SEAL Ø 11MM silicone seal, blue, for instruments 3-6mm, Length 2mm, reusable
04055207069783 - NA2024-04-09 SEALING MEMBRANE Ø 17MM yellow, Ø 17mm, PACK=10 PCS, for instruments from 3 to 6mm
04055207056691 - NA2024-04-08 LASER WORKING ELEMENT PASSIVE 12/30° closed, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayon
04055207056707 - NA2024-04-08 LASER WORKING INSERT 12/30° compatible with telescopes Ø 4mm, with locking mechanism for laser fiber, bayonet-lock, reusable
04055207057247 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 22FR with lateral guide, distal end straight, reusable
04055207057254 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 24FR with lateral guide, distal end straight, reusable
04055207057261 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 22FR with lateral guide, distal end straight, reusable
04055207057278 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 24FR with lateral guide, distal end straight, reusable
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