FDA.reportPublic FDA data

N/A

Primary DI
00847536003835
Brand
N/A
Company
Reverse Medical Corporation
Model
RMCS-2.75US
Device description
RMCS-2.75US DETACHMENT CABLE SET
Published
2015-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133282000REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMReverse Medical Corporation2013-11-27KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536003835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536003835008475360038358475360038350847536003835

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry, secure place

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
963324913
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536003552ReverseTMMIC-021-1502016-08-19
00847536003569ReverseTMMIC-027-1502016-08-12
00847536020825MVP®MVP-7Q2019-08-01
00847536004009MVP®MVP-9Q2015-10-23
00847536003873N/AED2-RM-US2015-10-23
00847536003583MVP®MVP-3US2015-09-11
00847536003606MVP®MVP-5US2015-09-11
00847536021945ReverseTMMIC-021-1502016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488710Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28