AccessGUDID - DEVICE: NA (06932503551038)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: NPFS01-02023230
Catalog Number: NPFS01-02023230
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503551038
Issuing Agency: GS1
Device Count: 1

Device Description: Double color handle，Oval，3 * 3 wire,Diameter is 20 mm,outer diameter is 7Fr,working length is 2300mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Flexible polypectomy snare, single-use	A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.
Rigid polypectomy snare, single-use	A sterile, rigid device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It typically consists of a rigid insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Flexible polypectomy snare, single-use

A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.

Rigid polypectomy snare, single-use

A sterile, rigid device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It typically consists of a rigid insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FDI	Snare, Flexible

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: March 11, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
26932503551032	10	16932503551035		In Commercial Distribution	case
16932503551035	10	06932503551038		In Commercial Distribution	box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: NA (06932503551038)