FDA.reportPublic FDA data

Mammotome revolve MammoMark

Primary DI
00841911101604
Brand
Mammotome revolve MammoMark
Company
DEVICOR MEDICAL PRODUCTS, INC.
Model
MMK0802
Catalog number
MMK0802
Device description
MammoMARK Biopsy Site Identifier- 8G- U Shape- Non CE
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPClip, Implantable
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082278000MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERSEthicon Endo-Sugery, LLC2008-12-16NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841911101601PackageGS110In Commercial Distribution
00841911101604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191110160110841911101601
00841911101604008419111016048419111016040841911101604

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge0

Contacts#

Phone, Email table
PhoneEmail
+1(877)926-2666customersupport@mammotome.com

Regulatory Flags#

DUNS number
961832156
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
00841911103776Mammotome PrimaMRPROBE08CA0007780012026-06-09
00841911103653HydroMARKCA0005150064010-05-08-T42026-07-07
00841911100003HydroMarkCA0004100044010-01-08-S12018-10-10
00841911100010HydroMarkCA0004100014010-01-08-T12018-10-10
00841911100027HydroMarkCA0004100024010-01-08-T32018-10-10
00841911100034HydroMarkCA0004100034010-01-08-T42018-10-10
00841911100041HydroMarkCA0004110014010-01-11-T12018-10-10
00841911100058HydroMarkCA0004110024010-01-11-T32018-10-10
00841911100065HydroMarkCA0004110034010-01-11-T42018-10-10
00841911100072HydroMarkCA0004070014010-02-15-S12016-12-13
00841911100089HydroMarkCA0004070024010-02-15-S32016-12-13
00841911100096HydroMarkCA0004070034010-02-15-T12016-12-13
00841911100102HydroMarkCA0004070044010-02-15-T32016-12-13
00841911100119HydroMarkCA0004070054010-02-15-T42016-12-13
00841911100126HydroMarkCA0004090014010-02-18-T32016-12-13
00841911100133HydroMarkCA0004130014010-03-09-T12016-12-13
00841911100140HydroMarkCA0004130024010-03-09-T32016-12-13
00841911100157HydroMarkCA0004120014010-03-15-T1-SHORT2016-12-13
00841911100164HydroMarkCA0004120024010-03-15-T3-SHORT2016-12-13
00841911100171HydroMarkCA0004080044010-04-09-S32018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704936882WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936899WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936905WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936912WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936929WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936936WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936943WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936950WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936967WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936974WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936981WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936998WECKTELEFLEX INCORPORATEDFZP2026-10-20
00817295021166InradInradNEU2026-10-08
00817295021197InradInradNEU2026-10-08
00817295021401InradInradNEU2026-10-08
00817295021418InradInradNEU2026-10-08
00817295021425InradInradNEU2026-10-08
00884450554883SCOUT®MERIT MEDICAL SYSTEMS, INC.NEU2026-10-07
14026704937001WECKTELEFLEX INCORPORATEDFZP2026-03-30
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00841911102397Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102427Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102434Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102441Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102465Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102472Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2022-03-02
00841911102304Mammotome HydromarkDEVICOR MEDICAL PRODUCTS, INC.NEU2022-02-08
00841911102311Mammotome HydromarkDEVICOR MEDICAL PRODUCTS, INC.NEU2022-02-08
00841911102052HydroMARK Breast Biopsy Site MarkerDEVICOR MEDICAL PRODUCTS, INC.NEU2020-03-25