EndoClot Plus Co.,Ltd.

Address:Unit 101, B8 Building, 218 Xinghu Street,Suzhou Jiangsu,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Submucosal Injection Agent (PLL) (4) Compressor, Air, Portable (BTI) (1) Hemostatic Device For Endoscopic Gastrointestinal Use (QAU) (1) Laparoscope, General & Plastic Surgery (GCJ) (1) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

EndoClot - 16972011720011 Catalog Number :

Device Description : EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS

Device Class :

Duns Number: 544357082

Premarket Exempt : No

Product Code : QAU

Prescription Use : Yes

Device Count : 1

EndoClot PHS - 16972011720028 Catalog Number : EPK2303-01

Device Class :

Duns Number: 544357082

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

EndoClot PHS - 16972011720035 Catalog Number : EPK2305-01

Device Class :

Duns Number: 544357082

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

EndoClot Applicator - 16972011720110 Catalog Number :

Device Class : 2

Duns Number: 544357082

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

EndoClot - 16972011720219 Catalog Number : SIS-30

Device Description : EndoClot Submucosal Injection SystemEndoClot® Submucosal Injection Agent is inte EndoClot Submucosal Injection SystemEndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal liftof polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare orendoscopic device.

Device Class : 2

Duns Number: 544357082

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

EndoClot - 16972011720226 Catalog Number :

Device Class : 2

Duns Number: 544357082

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

EndoClot SIS - 16972011720240 Catalog Number : SIS-30-01

Device Description : EndoClot Submucosal Injection System

Device Class :

Duns Number: 544357082

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

EndoClot SIS - 16972011720257 Catalog Number : SIS-15-01

Device Description : EndoClot Submucosal Injection System

Device Class :

Duns Number: 544357082

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

EndoClot Air Compressor - 16972011720318 Catalog Number :

Device Class : 2

Duns Number: 544357082

Premarket Exempt : Yes

Product Code : BTI

Prescription Use : Yes

Device Count : 1

EndoClot - 16972011720516 Catalog Number :

Device Description : EndoClot® Air Compressor Connecting Tube

Device Class : 1

Duns Number: 544357082

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

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