TEMNO® CT1811/B

GUDID 20884450444171

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 ID20884450444171
NIH Device Record Keyc0a0d9f7-f64e-4997-b516-7a0aca362803
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMNO®
Version Model Number10884450444174
Catalog NumberCT1811/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
GS100884450444177 [Unit of Use]
GS100884450444177 [Unit of Use]
GS100884450444177 [Unit of Use]
GS110884450444174 [Primary]
GS110884450444174 [Primary]
GS110884450444174 [Primary]
GS120884450444171 [Package]
Contains: 10884450444174
Package: [18 Units]
In Commercial Distribution
GS120884450444171 [Package]
Contains: 10884450444174
Package: [18 Units]
In Commercial Distribution
GS120884450444171 [Package]
Contains: 10884450444174
Package: [18 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 Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [TEMNO®]

2088445044321110884450443214
2088445044460710884450444600
2088445044427010884450444273
2088445044424910884450444242
2088445044418810884450444181
2088445044415710884450444150
2088445044411910884450444112
2088445044417110884450444174
2088445044456010884450444563

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