Kit Ke217 Colecistectomia

FDA UDI

Class I (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: KIT KE217 COLECISTECTOMIA FDA UDI
Generic Name: Rigid endoscopic grasping forceps, single-use FDA UDI
Device Name: Kit Contains: CTF03, 5x100 Kii Fios Z-THR 6/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX FDA UDI
Model / Reference: GK286 FDA UDI
Description: Kit Contains: CTF03, 5x100 Kii Fios Z-THR 6/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915135533 FDA UDI
FDA Product Code: NWV FDA UDI
GEI FDA UDI
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Rigid endoscopic grasping forceps, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.1720 FDA UDI
878.4400 FDA UDI
876.1500 FDA UDI
878.4300 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ligation clip, metallic Laparoscopic access cannula, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Tissue extraction bag

Kit Ke217 Colecistectomia by Applied Medical Resources Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 34e99b61-f458-4e3b-b16a-95bf174e5767 34 fields · synced May 30, 2026