003997-901 Gauze Sack and O-Ring

GUDID 00821925000247

Gyrus Acmi, Inc.

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Primary Device ID00821925000247
NIH Device Record Key603a6e9e-3921-4a80-8bc2-fc37db1a5e86
Commercial Distribution StatusIn Commercial Distribution
Brand Name003997-901 Gauze Sack and O-Ring
Version Model Number003997-901
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 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
GS100821925000247 [Package]
Contains: 00821925037908
Package: [10 Units]
In Commercial Distribution
GS100821925037908 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-10

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