FDA.report

MicroFrance®

Primary DI
10381780101192
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CP975
Catalog number
CP975
Device description
MicroFrance® Belloc angled rasp, cross-cutting, 190 mm
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
KBARASP, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KBARasp, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780101192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010119210381780101192

GMDN Terms

TermDefinition
Plastic surgery file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It is typically a one-piece instrument which resembles a coarse or fine file, but with sharp cutting projections instead of lines and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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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