FDA.report

Disposable Endoscopic Biopsy Forceps

Primary DI
16971944914979
Brand
Disposable Endoscopic Biopsy Forceps
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
AD1816BWCP-A
Device description
Disposable Endoscopic Biopsy Forceps
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16971944914979PackageGS110In Commercial Distribution
26971944914976PackageGS15In Commercial Distribution
06971944914972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697194491497916971944914979
2697194491497626971944914976
06971944914972069719449149726971944914972

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
544587864
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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26971944910329Closed Suction CathetersH2184002025-03-04
26971944910336Closed Suction CathetersH2106002025-03-04

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