Standard Set 194 Z

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: STANDARD SET 194 Z FDA UDI
Generic Name: Tissue extraction bag FDA UDI
Device Name: Kit Contains: CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX FDA UDI
Model / Reference: GK236 FDA UDI
Description: Kit Contains: CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915131313 FDA UDI
FDA Product Code: GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Tissue extraction bag FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 Tissue extraction bag

Standard Set 194 Z by Applied Medical Resources Corp. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 464aa1f2-35df-49f4-aa37-9c8438a0a0bf 34 fields · synced May 30, 2026