FDA.report

MicroFrance®

Primary DI
10381780100430
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CP821D
Catalog number
CP821D
Device description
SCAPEL HANDLE CP821D 150MM
Published
2017-06-02
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
GDZHANDLE, SCALPEL

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780100430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010043010381780100430

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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

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 DIBrandCompanyProduct codePublished
00190776418038MillenniumAvalign Technologies, Inc.GDZ2026-03-23
16937372521523comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521530comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521547comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521554comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521561comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521578comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
B382SD4811280Surgical DirectSurgical Direct, Inc.GDZ2026-02-16
00190776416157MillenniumAvalign Technologies, Inc.GDZ2026-02-06
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
09348811000019INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000095INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000132INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000149INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000170INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000187INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000194INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000200INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000217INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000224INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014146INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014856INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014863INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811151452INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-01-22
00841013120480Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-06
00841013124327American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02
00841013124334American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02