FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780101086
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CP961
Catalog number
CP961
Device description
MicroFrance® Breast aerola marker, double serrated, 38 x 42mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780101086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010108610381780101086

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780093558Integra® MicroFrance®CEV504A2016-09-21
10381780093565Integra® MicroFrance®CEV504B2016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154255LEVEL ONE EXTREMITYKLS-Martin L.P.FTY2026-05-25
00810180843331Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
08806373887703BENCOX Surgical InstrumentsCorentec Co., LtdFTY2026-02-23
00842071152963AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
B382SD2644404000Surgical DirectSurgical Direct, Inc.FTY2026-02-16
00757770421848Bausch + LombBausch & Lomb IncorporatedFTY2026-02-11
03662663108072Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
03662663108089Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
B382SD91328410000Surgical DirectSurgical Direct, Inc.FTY2026-02-10
08681506801500SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-02-09
08681506801593ScharfSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-01-31
00847538005479Patella CaliperSYMMETRY MEDICAL INC.FTY2025-12-10
09348811038784INKAThe Trustee for KAISER FAMILY TRUSTFTY2025-12-02
00810207782599Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFTY2025-11-24
00887868287503Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-14
04719846016576CharderCHARDER ELECTRONIC CO., LTD.FTY2025-11-13
00763000684044Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FTY2025-09-21
B382SD1327110040Surgical DirectSurgical Direct, Inc.FTY2025-09-09
04059453050144Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-08-25
00757770405237Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413102Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770450831Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770676309Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413843Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770422531Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770669615Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
20197344154651MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
00190776406899MillenniumAvalign Technologies, Inc.FTY2025-07-25
04059453186676Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-07-23
B382SD1325910000Surgical DirectSurgical Direct, Inc.FTY2025-07-23