TEMNO Evolution® CTT1611/B

GUDID 20884450443358

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID20884450443358
NIH Device Record Key45c7d239-b257-491a-b119-19c608877865
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMNO Evolution®
Version Model Number10884450443351
Catalog NumberCTT1611/B
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
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 Datetrue
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
GS100884450443354 [Unit of Use]
GS100884450443354 [Unit of Use]
GS100884450443354 [Unit of Use]
GS110884450443351 [Primary]
GS110884450443351 [Primary]
GS110884450443351 [Primary]
GS120884450443358 [Package]
Contains: 10884450443351
Package: [12 Units]
In Commercial Distribution
GS120884450443358 [Package]
Contains: 10884450443351
Package: [12 Units]
In Commercial Distribution
GS120884450443358 [Package]
Contains: 10884450443351
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy needle
FCGBiopsy needle
FCGBiopsy needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [TEMNO Evolution®]

2088445044336510884450443368
2088445044323510884450443238
2088445044340210884450443405
2088445044360010884450443603
2088445044324210884450443245
2088445044339610884450443399
2088445044341910884450443412
2088445044356310884450443566
2088445044338910884450443382
2088445044342610884450443429
2088445044335810884450443351
2088445044346410884450443467

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