FDA.report

CorVocet™

Primary DI
10884450373597
Brand
CorVocet™
Company
Merit Medical Systems, Inc.
Model
00884450373590
Catalog number
CORA2010
Published
2018-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K153337000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K153337000Corvocet Biopsy SystemMerit Medical Systems, Inc.2016-03-25KNW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450373597PackageGS15In Commercial Distribution
20884450373594PackageGS14In Commercial Distribution
00884450373590PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

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

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