FDA.reportPublic FDA data

TEMNO Evolution®

Primary DI
10884450443382
Brand
TEMNO Evolution®
Company
Merit Medical Systems, Inc.
Model
10884450443382
Catalog number
CTT1811/B
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450443389PackageGS112In Commercial Distribution
10884450443382PrimaryGS10
00884450443385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445044338920884450443389
1088445044338210884450443382
00884450443385008844504433858844504433850884450443385

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901588BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08033860002398BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002633BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860019976BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860027179BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043421BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043438BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002572BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860016272BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860027810BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041847BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041861BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041885BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041908BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041915BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041922BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041939BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041953BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041960BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860001728BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001742BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001766BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03