FDA.reportPublic FDA data

TEMNO®

Primary DI
20884450444584
Brand
TEMNO®
Company
Merit Medical Systems, Inc.
Model
10884450444587
Catalog number
T1820/B
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902319000BAUER TEMNO BIOPSY NEEDLEProact, Ltd.1990-09-06FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450444584PackageGS118In Commercial Distribution
10884450444587PrimaryGS10
00884450444580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445044458420884450444584
1088445044458710884450444587
00884450444580008844504445808844504445800884450444580

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450031469Merit Medical®Initial ReleaseK09-02709B2026-10-07
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295021081InradInradFCG2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021388InradInradFCG2026-10-08
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884521833043SharkCoreCovidien LPFCG2026-09-06
10884521833050SharkCoreCovidien LPFCG2026-09-06
10884521833067SharkCoreCovidien LPFCG2026-09-06
10884521833074SharkCoreCovidien LPFCG2026-09-06
10884521833081SharkCoreCovidien LPFCG2026-09-06
10884521833012BeaconCovidien LPFCG2026-09-05
10884521833029BeaconCovidien LPFCG2026-09-05
10884521833036BeaconCovidien LPFCG2026-09-05
10884521833142BeaconCovidien LPFCG2026-09-05
10884521833159BeaconCovidien LPFCG2026-09-05
10884521833166BeaconCovidien LPFCG2026-09-05
04048223088388ChibaSonoPajunk GmbH MedizintechnologieFCG2026-06-10
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
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02