FDA.report

Olympus

Primary DI
14953170381925
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
NA-201SX-4022
Device description
Single Use Aspiration Needle
Published
2018-07-02
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

Related Records

Contact Domains

Product Codes

CodeName
FCGBiopsy needle

Product Code Classifications

CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14953170381925PackageGS15In Commercial Distribution
04953170381928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1495317038192514953170381925
04953170381928049531703819284953170381928

GMDN Terms

TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Sterilization Methods

Method

Contacts

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

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