FDA.reportPublic FDA data

Biopsy Forceps

Primary DI
00816207020716
Brand
Biopsy Forceps
Company
ENDO-THERAPEUTICS, INC.
Model
SU-111-315
Catalog number
SU-111-315
Device description
Flexible bronchoscopic biopsy forceps
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWHForceps, Biopsy, Bronchoscope (Non-Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWHForceps, Biopsy, Bronchoscope (Non-Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816207020713PackageGS110Not in Commercial Distribution
00816207020716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702071310816207020713
00816207020716008162070207168162070207160816207020716

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
Length160Centimeter
Outer Diameter1.7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
844-400-3636customerservice@endotherapeutics.com

Regulatory Flags#

DUNS number
825239189
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816207021744EndoTExtractorET2070ET20702026-03-03
10816207021741EndoTExtractorET2070ET20702026-03-03
00816207021386EndoTBasketET2046ET20462025-02-26
10816207021383EndoTBasketET2046ET20462025-02-26
00816207021720Biopsy BrushLBB-95LBB-952025-02-26
00816207020181BioCeps Biopsy ForcepsET1400ET14002016-09-22
00816207020242ezSnare Polypectomy SnareET1800ET18002016-09-22
00816207020259ezSnare Polypectomy SnareET1801ET18012016-09-22
00816207020266ezSnare Polypectomy SnareET1802ET18022016-09-22
00816207020273ezSnare Polypectomy SnareET1803ET18032016-09-22
00816207020280ezSnare Polypectomy SnareET1804ET18042016-09-22
00816207020297ezSnare Polypectomy SnareET1805ET18052016-09-22
00816207020303ezSnare Polypectomy SnareET1806ET18062016-09-22
00816207020310ezSnare Polypectomy SnareET1807ET18072016-09-22
00816207020327ezSnare Polypectomy SnareET1814ET18142016-09-22
00816207020624Polypectomy Snare, Oval-LargeSGO-1315LSGO-1315L2016-09-20
00816207020631Polypectomy Snare, Oval - MediumSGO-1315MSGO-1315M2016-09-20
00816207020648Polypectomy Snare, Oval - SmallSGO-1315SSGO-1315S2016-09-20
00816207020655Polypectomy Snare, Oval - Extra LargeSGO-1315XLSGO-1315XL2016-09-20
00816207020662Polypectomy Snare, Oval - LargeSGO-1622LSGO-1622L2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816207021454BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2021-01-29
00816207021447BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2021-01-29
10816207021451BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2021-01-29
04055207039267NARichard Wolf GmbHBWH2016-09-29
04055207014783NARichard Wolf GmbHBWH2016-09-28
04055207014790NARichard Wolf GmbHBWH2016-09-28
04055207033869NARichard Wolf GmbHBWH2016-09-28
04055207045886NARichard Wolf GmbHBWH2016-09-28
04055207045893NARichard Wolf GmbHBWH2016-09-28
04055207045909NARichard Wolf GmbHBWH2016-09-28
04055207045916NARichard Wolf GmbHBWH2016-09-28
08714729821717Radial Jaw 4BOSTON SCIENTIFIC CORPORATIONBWH2016-09-24
08714729821731Radial Jaw 4BOSTON SCIENTIFIC CORPORATIONBWH2016-09-24
08714729821748Radial Jaw 4BOSTON SCIENTIFIC CORPORATIONBWH2016-09-24
00816207020235BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-22
00816207020228BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-22
10816207020232BioCeps Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-22
00816207020709Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-20
10816207020706Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-20
10816207020713Biopsy ForcepsENDO-THERAPEUTICS, INC.BWH2016-09-20