MAJ
RECEIVER DISH STAND SUPPLEMENTARY SET - MAJ-1978
Device Description
A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FDF
Device Name: Colonoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with colonoscope
Definition: To examine or perform procedures in the colon or rectum 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: Inserted into anus
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: colon or rectum
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170305887
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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