FDA.report

MicroFrance®

Primary DI
10381780110255
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO813
Catalog number
MCO813
Device description
MicroFrance® Sterkers ball probe 1 mm
Published
2018-01-12
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
KAKPROBE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780110255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178011025510381780110255

GMDN Terms

TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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

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