Specula, Reusable for 5211,Size 2.5mm
ADC® - 5211-1
Device Description
A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 2.5 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: EPY
Device Name: Speculum, Ent
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.1800
Third Party Flag: N
Medical Specialty: SU
Device Identifiers
Device Id: 00634782540166
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00634782840167
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Master Case
Device Id: 00634782840167
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00634782040338
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Inner Pack
Device Id: 00634782040338
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
