FDA.reportPublic FDA data

CITEC

Primary DI
06975238201977
Brand
CITEC
Company
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Model
DH-BE-232300CS
Device description
Disposable Biopsy Forceps, 2.3*2300mm, Alligator Cup with Spike
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
16975238201974PackageGS110In Commercial Distribution
06975238201977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697523820197416975238201974
06975238201977069752382019776975238201977

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.

Regulatory Flags#

DUNS number
545070385
Device count
1
Premarket exempt
true
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
06975238202561CITECCIT-PT-01S2024-07-12
06975238201984CITECDH-BE-231600CS2024-01-18
16975238201974CITECDH-BE-232300CS2024-01-18
16975238201981CITECDH-BE-231600CS2024-01-18
06975238201151citecSSK-35R2023-01-03
06975238201144citecSSK-35W2023-01-03
16975238201158citecSSK-35R2023-01-03

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
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628536Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628550Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03