Gyrus ACMI, Inc.

GUDID 00821925041349

FLEX-CATCH 4 WIRE NITINOL BASKET

Gyrus Acmi, Inc.

Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set Stone/foreign-body extraction set
Primary Device ID00821925041349
NIH Device Record Key7c01b157-64bf-4653-a1d3-dd2bd99477eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGyrus ACMI, Inc.
Version Model NumberNT4F19115
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925041349 [Primary]

FDA Product Code

FGODISLODGER, STONE, FLEXIBLE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-05
Device Publish Date2020-01-28

Devices Manufactured by Gyrus Acmi, Inc.

00821925000292 - SURGIFLEX2024-07-15 SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm
00821925015708 - Gyrus ACMI2024-06-18 SCHUKNECHT CRESCENT FLUOROPLASTIC
00821925041394 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR
00821925041400 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
00821925041417 - InstaClear2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
00821925041424 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
00821925041431 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
00821925041448 - InstaClear2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
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