VACURETTE CURVED 9MM 10/PKG

GUDID 00821925001015

Gyrus Acmi, Inc.

Intrauterine curette, suction Intrauterine curette, suction Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use Surgical suction system collection container, single-use
Primary Device ID00821925001015
NIH Device Record Key27932c64-1d78-4b49-8a26-1c1f0f8b1c1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVACURETTE CURVED 9MM 10/PKG
Version Model Number21552
Company DUNS007198742
Company NameGyrus Acmi, Inc.
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 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
GS100821925001015 [Package]
Contains: 00821925037526
Package: [10 Units]
In Commercial Distribution
GS100821925037526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHISYSTEM, ABORTION, VACUUM
HHKCurette, Suction, Endometrial (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-11

Devices Manufactured by Gyrus Acmi, Inc.

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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
00821925041455 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
00810008180983 - nCare2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
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