Gyrus ACMI, Inc.

GUDID 00821925041349

FLEX-CATCH 4 WIRE NITINOL BASKET

Gyrus Acmi, Inc.

Stone/foreign-body extraction set

Primary Device ID	00821925041349
NIH Device Record Key	7c01b157-64bf-4653-a1d3-dd2bd99477eb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gyrus ACMI, Inc.
Version Model Number	NT4F19115
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925041349 [Primary]

FDA Product Code

FGO	DISLODGER, STONE, FLEXIBLE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

[00821925041349]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-02-05
Device Publish Date	2020-01-28

Devices Manufactured by Gyrus Acmi, Inc.

00821925043916 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron
00821925043930 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043978 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043992 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
00821925044074 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
00821925002074 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002111 - USA Elite System	2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold

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