ACMI INSTRUMENT AI VERSITIP
ADAPTOR FOR 4.0 MM AND 5.0 MM LIGHT
GUIDES INTENDED TO INTERFACE SMITH
and NEPHEW GEMINI UNIVERSAL FIBER
OPTIC LIGHT CABLES WITH ACMI ENDOSCOPES
VERSITIP - 2141
Device Description
A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: GCJ
Device Name: Laparoscope, General & Plastic Surgery
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
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: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 03596010103291
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