GRI Medical & Electronic Technology Co., Ltd.

Address:1805 HONGGAO ROAD,JIAXING Zhejiang,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

Drape, surgical, exempt (PUI) (5) Restraint, protective (FMQ) (3) CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY (GEA) (1) Lancet, Blood (FMK) (1)

Premarket Exempt

No Yes

Clear

GRI - 16931918100067 Catalog Number :

Device Description : Gentleheel Devices are made of lower housing, upper housing, spring, blade, spri Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, blade holder, safety lock, button, etc. Materials of all components and package are medical grade and match the requirement of medical use. The products are EO sterilized.

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Alleset - 16931918110141 Catalog Number :

Device Description : Suction tubing 12ft with 1/4'' standard push-on Fitting, sterile_25ea/cs

Device Class : 1

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : No

Device Count : 1

Alleset - 16931918110202 Catalog Number :

Device Description : Hand Drape_114inx150in_Sterile_14ea/cs

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Beaver Visitec Inter - 16931918110288 Catalog Number :

Device Description : Back table cover_140cmX140cm_Handi-Bin_780EA/CS

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 780

Alleset - 16931918110509 Catalog Number :

Device Description : Bottom drape w/tape reinforced_69inx71in_Heavy Reinforced_Non-sterile_50ea/c

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 50

Alleset - 16931918110721 Catalog Number :

Device Description : Heel and Elbow Protector_9.5 x 9 x 3.5in (24 x 23 x 9cm)_36EA/CS

Device Class : 1

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : No

Device Count : 1

Alleset - 16931918110769 Catalog Number :

Device Description : Head Rest_Donut_9 x 2in (23 x 5cm)_36EA/CS

Device Class : 1

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : No

Device Count : 1

Alleset - 16931918110837 Catalog Number :

Device Description : Femoral Angiography Drape_87x169in_Non-Sterile_10EA/CS

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 10

Alleset - 16931918110882 Catalog Number :

Device Description : Head Rest_Donut Multiple_9 x 2in (23 x 5cm)_36EA/CS

Device Class : 1

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : No

Device Count : 1

Alleset - 16931918111100 Catalog Number :

Device Description : Back Table cover_44inx75in_Handi-Bin_320EA/CS

Device Class : 2

Duns Number: 679894738

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 320

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