FDA.report

MicroFrance®

Primary DI
10381780101260
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CP980-45
Catalog number
CP980-45
Device description
MicroFrance® Dufourmentel breast areola marker, 45mm
Published
2018-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications

CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780101260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010126010381780101260

GMDN Terms

TermDefinition
Skin marking guide, reusableA device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
276593071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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10381780093558Integra® MicroFrance®CEV504A2016-09-21
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10381780259367MicroFrance®CEV405UCEV405U2019-02-20
10381780259435MicroFrance®CEV531T3UCEV531T3U2019-02-20
10381780259503MicroFrance®CEV649B5UCEV649B5U2019-02-20
10381780259510MicroFrance®CEV649BGPUCEV649BGPU2019-02-20
10381780259572MicroFrance®CEV728BR5UCEV728BR5U2019-02-20
10381780259619MicroFrance®CEV8649B5UCEV8649B5U2019-02-20
10381780259626MicroFrance®CEV8649BGPUCEV8649BGPU2019-02-20
10381780259664MicroFrance®CEV891MUCEV891MU2019-02-20
10381780259695MicroFrance®CEV894MUCEV894MU2019-02-20
10381780259718MicroFrance®CEV895MUCEV895MU2019-02-20
10381780259794MicroFrance®CEV9649B5UCEV9649B5U2019-02-20
10381780259800MicroFrance®CEV9649BGPUCEV9649BGPU2019-02-20
10381780259879MicroFrance®CM107UCM107U2019-02-20
10381780259886MicroFrance®CM110UCM110U2019-02-20
10381780259893MicroFrance®CM111UCM111U2019-02-20
10381780259909MicroFrance®CM112UCM112U2019-02-20
10381780259916MicroFrance®CM113UCM113U2019-02-20
10381780259923MicroFrance®CM115UCM115U2019-02-20

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