ReSolve Mini™, StayFIX® RML27-12-SFX

GUDID 10884450445188

Merit Medical Systems, Inc.

Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain
Primary Device ID10884450445188
NIH Device Record Keybc187658-a90b-4b68-bd59-1d155f78d111
Commercial Distribution StatusIn Commercial Distribution
Brand NameReSolve Mini™, StayFIX®
Version Model Number00884450445181
Catalog NumberRML27-12-SFX
Company DUNS184763290
Company NameMerit Medical Systems, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450445181 [Primary]
GS100884450445181 [Primary]
GS100884450445181 [Primary]
GS100884450445181 [Primary]
GS110884450445188 [Package]
Contains: 00884450445181
Package: [5 Units]
In Commercial Distribution
GS110884450445188 [Package]
Contains: 00884450445181
Package: [5 Units]
In Commercial Distribution
GS110884450445188 [Package]
Contains: 00884450445181
Package: [5 Units]
In Commercial Distribution
GS110884450445188 [Package]
Contains: 00884450445181
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GBXCATHETER, IRRIGATION
GBXCATHETER, IRRIGATION
GBXCATHETER, IRRIGATION
GBXCATHETER, IRRIGATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by Merit Medical Systems, Inc.

10884450303631 - Advocate™2020-11-10
10884450445188 - ReSolve Mini™, StayFIX®2020-11-10
10884450445188 - ReSolve Mini™, StayFIX®2020-11-10
00884450338308 - Merit Medical®2020-11-09
00884450451724 - HeartSpan®2020-11-09
00884450451731 - HeartSpan®2020-11-09
00884450451748 - HeartSpan®2020-11-09
00884450451755 - HeartSpan®2020-11-09
00884450490846 - Arcadia™2020-11-09

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