Olymous WA64750A

GUDID 04042761067669

Jaws "HiQ+", 5 x 330 mm, assistant needle holder

OLYMPUS Winter & Ibe GmbH

Suturing needle holder, reusable
Primary Device ID04042761067669
NIH Device Record Key7b57b1a1-3a41-4b14-9d6c-2b0c0266af32
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlymous
Version Model NumberWA64750A
Catalog NumberWA64750A
Company DUNS316957240
Company NameOLYMPUS Winter & Ibe 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 Batchtrue
Serial Numberfalse
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

Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104042761067669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


[04042761067669]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-01-08
Device Publish Date2016-09-21

Devices Manufactured by OLYMPUS Winter & Ibe GmbH

04042761002981 - Olympus2025-10-03 Overflow tube, for suprapubic overflow controller
04042761009805 - Olympus2025-10-03 Handle "HiQ+", semi-inline S, ratchet
04042761009812 - Olympus2025-10-03 Handle "HiQ+", semi-inline S, unipolar
04042761010214 - Olympus2025-10-03
04042761010283 - Olympus2025-10-03 Jaws "HiQ+", 5 x 330 mm, with spike, biopsy forceps
04042761010290 - Olympus2025-10-03 Jaws "HiQ+", 5 x 430 mm, biopsy forceps, with spike
04042761010306 - Olympus2025-10-03 Jaws "HiQ+", 5 x 330 mm, biopsy forceps, severing
04042761010351 - Olympus2025-10-03 Jaws "HiQ+", 5 x 430 mm, hook scissors

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.