BALLOON SHEATH - MH-246R
Device Description
A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FED
Device Name: Endoscopic Access Overtube, Gastroenterology-Urology
Device Class: 2
Physical State: overtube
Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Endoscope inserted and advanced through center of device
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: various openings in gi and gu tract
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: ODG
Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class: 2
Physical State: ultrasound system and system accessories, endoscope
Definition: To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (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: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses ultrasound to visualize body cavities through endoscope
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: various body cavities, hollow organs, and canals in GI and GU tract
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170365130
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170365133
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170365133
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
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