BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

NA

DI: 00845854024877 · Model: 8191-01 · Conmed Corporation

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: NA
Primary DI: 00845854024877
Version / Model: 8191-01
Catalog Number: 8191-01
Company Name: Conmed Corporation
Labeler DUNS: 071595540
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 3
Public Version Date: 2020-10-16
Public Version Status: Update
Public Device Record Key: 9ab735ab-a1f7-4431-9de0-6648c446914b
Distribution End Date: 2020-10-15

Device Description

3DHD SINGLE CHANNEL STEREO ENDOSCOPE 10MM 0 DEGREE

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: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FET	Endoscopic video imaging system/component, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12991	Ear lobe perforator	An instrument used to pierce the lobe of the ear auricle (i.e., ear lobe) to create a hole in its tissue. It is typically designed as a device with a mechanism that forces a sharpened point (usually a starter earring) through the ear lobe by applying pressure to the handgrip. Although this device is primarily designed to piece the ear lobe, it can be used to pierce the ear cartilage and/or other parts of the body for, e.g., body piercing ornamentation purposes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	20845854024871	GS1
Primary	00845854024877	GS1

Customer Contacts

Phone: +1(800)237-0169
Email: [email protected]