FDA.reportPublic FDA data

TEMNO Elite™

Primary DI
10884450397937
Brand
TEMNO Elite™
Company
Merit Medical Systems, Inc.
Model
00884450397930
Catalog number
TE2020
Published
2022-11-02
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
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450397937PackageGS15In Commercial Distribution
20884450397934PackageGS14In Commercial Distribution
00884450397930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445039793710884450397937
2088445039793420884450397934
00884450397930008844503979308844503979300884450397930

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
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
false
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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095210CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095227CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095067CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-25
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00801741234187EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-09
10801741234153EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
10801741234160EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741236167EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
10801741234092EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234139EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
00801741234200EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234115EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234146EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234177EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10850075308016HYDRACELL-ORTHO-5RANFAC CORP.KNW2025-09-25
10850075308030HYDRACELL-ORTHO-10RANFAC CORP.KNW2025-09-25
10850075308047HYDRACELL-EXT-5RANFAC CORP.KNW2025-09-25
10850075308061HYDRACELL-EXT-10RANFAC CORP.KNW2025-09-25
08058983746639TRAP EASYH.S. HOSPITAL SERVICE SPAKNW2025-09-23
10810563022725OmniBone Bone Biopsy Kit with 11 Gauge 68mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18
10810563022732OmniBone Bone Biopsy Kit with 11 Gauge 108mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18