FDA.reportPublic FDA data

Single-use Biopsy Forceps

Primary DI
16971381251613
Brand
Single-use Biopsy Forceps
Company
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model
BFTN-1811
Device description
The single-use biopsy forceps has no physical or electrical connection to the endoscopic system and enters the human body through the instrument channel of the endoscope.
Published
2023-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric
GCLEsophagoscope, General & Plastic Surgery
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
GCLEsophagoscope, General & Plastic SurgeryGastroenterology, Urology2
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971381251613PackageGS110In Commercial Distribution
26971381251610PackageGS1100In Commercial Distribution
06971381251616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697138125161316971381251613
2697138125161026971381251610
06971381251616069713812516166971381251616

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544519831
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
true
Expiration date on label
false
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
06971381254228Single-use Flexible UreteroscopeSUV-2C-B2026-07-16
06971381252736Single-use Extraction BasketsEBF-1529CG2024-12-06
06971381252743Single-use Extraction BasketsEBF-1511CG2024-12-06
06971381252750Single-use Extraction BasketsEBF-1511SG2024-12-06
06971381252767Single-use Extraction BasketsEBF-1506SG2024-12-06
06971381252774Single-use Extraction BasketsEBF-1506CG2024-12-06
06971381252781Single-use Extraction BasketsEBF-1507SG2024-12-06
06971381252798Single-use Extraction BasketsEBF-1507CG2024-12-06
06971381252804Single-use Extraction BasketsEBF-1508SG2024-12-06
06971381252811Single-use Extraction BasketsEBF-1508CG2024-12-06
06971381252828Single-use Extraction BasketsEBF-2029SG2024-12-06
06971381252835Single-use Extraction BasketsEBF-2029CG2024-12-06
06971381252903Single-use Extraction BasketsEBF-2006SG2024-12-06
06971381252910Single-use Extraction BasketsEBF-2006CG2024-12-06
06971381252927Single-use Extraction BasketsEBF-2007SG2024-12-06
06971381252934Single-use Extraction BasketsEBF-2007CG2024-12-06
06971381252941Single-use Extraction BasketsEBF-2008SG2024-12-06
06971381252958Single-use Extraction BasketsEBF-2008CG2024-12-06
06971381252729Single-use Extraction BasketsEBF-1529SG2024-12-06
06971381253146Single-use Biopsy ForcepsBFUW-1029P-YG2023-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD13024290Surgical DirectSurgical Direct, Inc.FCL2026-07-14
06959664900000NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900215NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900222NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910788NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910801NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910832NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910863NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911365NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911372NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911389NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911396NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944035NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944042NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944059NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944066NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944073NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944080NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944097NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944103NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944110NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944127NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944134NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944141NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944165NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944172NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06975339628406Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628413Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03