FDA.reportPublic FDA data

Reference Plate Cover

Primary DI
04953170077746
Brand
Reference Plate Cover
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-996
Published
2021-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
PGUSpatial Imaging For Display Of Endoscope Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
PGUSpatial Imaging For Display Of Endoscope PositionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002749000ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13DThe Olympus Optical Co.2000-12-04FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170077746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170077746049531700777464953170077746

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926112PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926150PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926228PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926273PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926280PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928420PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928437PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25