FDA.report

MicroFrance®

Primary DI
10381780107361
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCM13-1
Catalog number
MCM13-1
Device description
CLAMP MCM13-1 SM GILBERT OBRIEN
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
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780107361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010736110381780107361

GMDN Terms

TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device intended to be sterilized prior to use.

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
true
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
00192896122840Alyea-Babcock Vasectomy ClampSONTEC INSTRUMENTS, INC.GDJ2026-03-19
00190776417574MillenniumAvalign Technologies, Inc.GDJ2026-03-04
00190776417550MillenniumAvalign Technologies, Inc.GDJ2026-02-27
00190776415587MillenniumAvalign Technologies, Inc.GDJ2026-01-28
00190776415235MillenniumAvalign Technologies, Inc.GDJ2026-01-27
00190776415570MillenniumAvalign Technologies, Inc.GDJ2026-01-27
00850037180004USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-07
00850037179886USB G2 Detachable Vascular Clamp System - 40mm Curved Arm SetUSB Medical LimitedGDJ2026-01-06
00850037179893USB G2 Detachable Vascular Clamp System - 40mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179909USB G2 Detachable Vascular Clamp System - Right Angle ArmUSB Medical LimitedGDJ2026-01-06
00850037179916USB G2 Detachable Vascular Clamp System - 60mm Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179923USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179930USB G2 Detachable Vascular Clamp System - 80mm Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179947USB G2 Detachable Vascular Clamp System - 94mm Gentle Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179954USB G2 Detachable Vascular Clamp System - 95mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179961USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179978USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179985USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179992USB G2 Detachable Vascular Clamp System - 93mm Curved ArmUSB Medical LimitedGDJ2026-01-06
03662663126373Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDJ2025-12-03
00190776411169MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411176MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411206MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411251MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776409937MillenniumAvalign Technologies, Inc.GDJ2025-09-08
04059453070975Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453073891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453175069Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-28
04059453136732Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25
04059453175083Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25