FDA.reportPublic FDA data

Olympus

Primary DI
14953170402606
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
NA-U201H-8022
Device description
Single Use Aspiration Needle NA-U201H
Published
2018-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181994000Single Use Aspiration Needle NA-U201HOlympus Medical Systems Corp.2018-10-31FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170402606PackageGS11In Commercial Distribution
04953170402609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317040260614953170402606
04953170402609049531704026094953170402609

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy handpiece/needleA sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use 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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
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

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