FDA.reportPublic FDA data

Radial Jaw 4

Primary DI
08714729837640
Brand
Radial Jaw 4
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00513380
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
OTC
false
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
08714729777915PackageGS15In Commercial Distribution
08714729777953PackageGS120In Commercial Distribution
08714729778011PackageGS140In Commercial Distribution
08714729837640PackageGS180Not in Commercial Distribution
08714729745648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729777915087147297779158714729777915
08714729777953087147297779538714729777953
08714729778011087147297780118714729778011
08714729837640087147298376408714729837640
08714729745648087147297456488714729745648

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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