FDA.report

Integra® MicroFrance®

Primary DI
10381780538998
Brand
Integra® MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CEV449
Catalog number
CEV449
Device description
Integra® MicroFrance® Mauras Guide sleeve for choledoscopy
Published
2024-05-29
Public version status
New
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

Product Codes

CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K993653000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K993653000MICRO-FRANCE TROCARS AND ACCESSORIESXomed, Inc.2000-06-09HET

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780093343PreviousGS10
10381780538998PrimaryGS10

GMDN Terms

TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. 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
false
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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