"MH
Sealing Assembly - MH-544
Device Description
A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.
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: ODD
Device Name: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device Class: 2
Physical State: catheter. may include radiopaque markings
Definition: To identify stones, tumors, or narrowing in the biliary tree.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Passed through an endoscope (duodenoscope) into the biliary duct to inject x-ray contract media into the biliary tree.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: biliary tree
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170043130
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
Device Id: 84953170043136
Device Type: Unit of Use
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