BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

INTERCEPTRE

DI: 03596010380944 · Model: 7208302 · Smith & Nephew, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: INTERCEPTRE
Primary DI: 03596010380944
Version / Model: 7208302
Catalog Number: 7208302
Company Name: Smith & Nephew, Inc.
Labeler DUNS: 045483575
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-08-30
Public Version: 6
Public Version Date: 2023-09-07
Public Version Status: Update
Public Device Record Key: 2856a7a5-ca22-4457-bd43-32ba0aaa2402
Distribution End Date: 2019-12-11

Device Description

INTERCEPTRE E/S HANDLE

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44680	Electrosurgical handpiece, reusable	A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010380944	GS1

Customer Contacts

Phone: +1(800)238-7538
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K970151	000