ITL ASIA PACIFIC SDN. BHD.

Address:Plot 17B, Lorong Bemban 2,Batu Gajah Perak,MY

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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

Needle, Hypodermic, Single Lumen (FMI) (3) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (3) Apparatus, Electrosurgical (HAM) (2) Device, Heat-Sealing (KSD) (2) Tray, Surgical, Instrument (FSM) (2) Device, General Purpose, Microbiology, Diagnostic (LIB) (1)

Premarket Exempt

No Yes

Clear

ITL Essential Laparoscopic Quiver Extendable - 19555240400854 Catalog Number : A100604

Device Description : Extendable laparoscopic quiver, PVC loop, polypropylene, individually packaged a Extendable laparoscopic quiver, PVC loop, polypropylene, individually packaged and sterile.Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

Device Class : 2

Duns Number: 597723837

Premarket Exempt : No

Product Code : HAM

Prescription Use : Yes

Device Count : 1

CrocClamp™ (Non-Reopening Clamp) - 19555240400960 Catalog Number : A100111

Device Description : CrocClamp™ (Non-Reopening Clamp) is a device that permanently and completely occ CrocClamp™ (Non-Reopening Clamp) is a device that permanently and completely occludes the tubing fluid path.

Device Class :

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : KSD

Prescription Use : Yes

Device Count : 4000

CrocClamp™ (Non-Reopening Clamp) - Red - 19555240401073 Catalog Number : A100111R

Device Class : 1

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : KSD

Prescription Use : Yes

Device Count : 4000

ITL Essentials™ Needle Mat (Sterile) - 19555240401080 Catalog Number : A500101

Device Description : ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite.

Device Class :

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Safety SubCulture Unit (SCU) - 19555240401110 Catalog Number : A100720

Device Description : SCU is a needleless device used to obtain samples from blood culture bottles and SCU is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury.

Device Class :

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : Yes

Device Count : 1

SampLok® Safety Adapter Cap with male luer - 19555240401134 Catalog Number : A100710

Device Description : SampLok® Adaptor Cap assembled with PP Luer, Sterile;Intended to facilitate coll SampLok® Adaptor Cap assembled with PP Luer, Sterile;Intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes

Device Class : 2

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA, FMI

Prescription Use : Yes

Device Count : 1

ITL Essential Standard Quiver - 19555240401141 Catalog Number : A100398

Device Description : Standard quiver, PVC loop, polypropylene, individually packaged and sterile.Devi Standard quiver, PVC loop, polypropylene, individually packaged and sterile.Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

Device Class : 2

Duns Number: 597723837

Premarket Exempt : No

Product Code : HAM

Prescription Use : Yes

Device Count : 1

SampLok® System with Hinged Lid - 19555240401158 Catalog Number : A100645

Device Description : SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Indi SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile;Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

Device Class : 2

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA, FMI

Prescription Use : Yes

Device Count : 1

SampLok® System with No Lid - 19555240401165 Catalog Number : A100500

Device Description : SampLok® System with No Lid, TR Blue, Assembled with PP Luer, Individual Package SampLok® System with No Lid, TR Blue, Assembled with PP Luer, Individual Packaged, Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.

Device Class : 2

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA, FMI

Prescription Use : Yes

Device Count : 1

ITL Essentials™ Sharps Passing Tray, Sterile - 19555240401172 Catalog Number : A500103

Device Description : ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instr ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped syringes during surgery. For single use only

Device Class : 1

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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