FDA.reportPublic FDA data

Olympus

Primary DI
14953170030656
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FB-39Q-1
Device description
FB-39Q-1 SWINGJAW BILIARY BIOP W/RAT TOO
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCLFORCEPS, BIOPSY, NON-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170030656PackageGS11In Commercial Distribution
04953170030659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317003065614953170030656
04953170030659049531700306594953170030659

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, reusableA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
14953170467377SINGLE USE DISTAL COVERMAJ-2315N61920012026-03-06
04953170467288ULTRASONIC PROBEUM-3R-3N53871402026-01-21
04953170467318ULTRASONIC PROBEUM-G20-29R-3N53872402026-01-21
14953170466219Single Use Cytology Brush VBC-V600P-3010N36258402026-01-19
14953170466349Single Use 3-Lumen Needle Knife VKD-V441MN54207402025-12-18
14953170466356Single Use 3-Lumen Needle Knife VKD-V451MN54208402025-12-18
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170421815Reusable Cordless TransducerTD-410N61329402025-12-04
14953170439992THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cmTB2-0520FCR50010082025-12-04
14953170440004THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cmTB2-0525FCR50010092025-12-04
14953170440011THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cmTB2-0535FCR50010102025-12-04
14953170440028THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cmTB2-0545FCR50010112025-12-04
04953170442353ULTRASONIC BIPOLAR GENERATORUSG-410N61924402025-12-04
04953170442445Update Tool for USG-410MAJ-2467N61925402025-12-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8019N62211302025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HNA-U210H-8022N62213302025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941513200089Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
00190776418021MillenniumAvalign Technologies, Inc.FCL2026-03-23
06970671381569AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2026-03-23
G3731433010Zinnanti SurgicalZinnanti Surgical Design Group IncFCL2026-03-04
00190776415617MillenniumAvalign Technologies, Inc.FCL2026-01-28
18051887049841THD BIOPSYTHD SPAFCL2026-01-07
18051887049865THD BIOPSYTHD SPAFCL2026-01-07
18051887049889THD BIOPSYTHD SPAFCL2026-01-07
06970671381026AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381040AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381187AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381200AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381248AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381323AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381347AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381491AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381545AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970800684059AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381361AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
06970671381385AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
00194613029449MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029456MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029463MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029470MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613034511MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01