FDA.reportPublic FDA data

CorVocet™

Primary DI
20884450333376
Brand
CorVocet™
Company
Merit Medical Systems, Inc.
Model
00884450333372
Catalog number
CORC1815B/A
Published
2018-07-12
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
K151373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151373000Corvocet Coaxial IntroducerMerit Medical Systems, Inc.2015-08-07FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450333379PackageGS15In Commercial Distribution
20884450333376PackageGS14In Commercial Distribution
00884450333372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445033337910884450333379
2088445033337620884450333376
00884450333372008844503333728844503333720884450333372

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
00884450148228Merit Medical®Initial ReleaseK09-09226C2026-08-19
00884450428474Merit Medical®Initial ReleaseK10-04389A2026-08-19
00884450432365Merit Medical®Initial ReleaseK10-05106A2026-08-18
00884450476079CorVocet™BCORA1410S2026-08-18
00884450476093CorVocet™BCORA14152026-08-18
00884450838211Prelude Roadster™APG7F45SX2026-08-18
00884450457535C2 CryoBalloon™AFG-10402026-08-17
00884450458204DuraMax®BH7871030280312026-08-17
00884450531969Prelude Roadster™00884450531969PG6F45S2022-07-20
00884450122471Merit Medical®Initial ReleaseK08-01887B2026-08-14
00884450428245Merit Medical®Initial ReleaseK10-05700A2026-08-15
00884450467220Merit Medical®Initial ReleaseK09-05248N2026-08-14
00884450488775Merit Medical®Initial ReleaseK10T-04423Q2026-08-14
00884450488843Merit Medical®Initial ReleaseK12T-127422026-08-15
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
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