SPINR™ 5X-GW

GUDID 10884450834265

Merit Medical Systems, Inc.

Torque manipulation device
Primary Device ID10884450834265
NIH Device Record Keyb40636f5-b702-4b31-93a1-2738e443dec9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINR™
Version Model NumberB
Catalog Number5X-GW
Company DUNS184763290
Company NameMerit Medical Systems, 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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450834268 [Primary]
GS110884450834265 [Package]
Contains: 00884450834268
Package: [5 Units]
In Commercial Distribution

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-13
Device Publish Date2025-02-05

On-Brand Devices [SPINR™]

1088445027724600884450277249
1088445027722200884450277225
10884450834265B

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