FDA.reportPublic FDA data

Radial Jaw 4

Primary DI
08714729745662
Brand
Radial Jaw 4
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00513400
Device description
Single-Use Biopsy Forceps
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
08714729777922PackageGS15In Commercial Distribution
08714729777960PackageGS120In Commercial Distribution
08714729778028PackageGS140In Commercial Distribution
08714729837664PackageGS180Not in Commercial Distribution
08714729745662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729777922087147297779228714729777922
08714729777960087147297779608714729777960
08714729778028087147297780288714729778028
08714729837664087147298376648714729837664
08714729745662087147297456628714729745662

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421723Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421730Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421747Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421754Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421761Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421778Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421785Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421792Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421808Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421815Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421822Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421839Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421846Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421853Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421860Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421877Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421884Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421891Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421907Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421914Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421921Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421938Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421945Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421952Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421969Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421976Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421983Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421990Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08051887049837THD BIOPSYTHD SPAFCL2026-01-07
08051887049851THD BIOPSYTHD SPAFCL2026-01-07