GOLDENBERG CUTTING BLOCK

GUDID 00821925023383

Gyrus Acmi, Inc.

Surgical implant template, reusable
Primary Device ID00821925023383
NIH Device Record Key07a70fb5-f3b0-4660-a9cb-b42d85827304
Commercial Distribution StatusIn Commercial Distribution
Brand NameGOLDENBERG CUTTING BLOCK
Version Model Number70135800
Company DUNS007198742
Company NameGyrus Acmi, Inc.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925023383 [Primary]

FDA Product Code

JXSBLOCK, CUTTING, ENT, STERILE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


[00821925023383]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-12
Device Publish Date2018-09-11

Devices Manufactured by Gyrus Acmi, Inc.

00821925043916 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron
00821925043930 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043978 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043992 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
00821925044074 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
00821925002074 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002111 - USA Elite System2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.