Standard Set 400 Z

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: Standard Set 400 Z FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: Kit includes: CTR22, 5x100 Kii LP OPT ZTHR 6/BX CTF73, Kii 12x100 Fios Z-THR 6/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX C6003, VALVE WITH DUAL BAG TUBING, 12/BX FDA UDI
Model / Reference: CK101 FDA UDI
Description: Kit includes: CTR22, 5x100 Kii LP OPT ZTHR 6/BX CTF73, Kii 12x100 Fios Z-THR 6/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX C6003, VALVE WITH DUAL BAG TUBING, 12/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915134956 FDA UDI
FDA Product Code: FHF FDA UDI
GCJ FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4370 FDA UDI
876.1500 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: Laparoscopic access cannula, single-use Surgical irrigation/aspiration tubing set

Standard Set 400 Z by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical irrigation/aspiration tubing set.

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INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · Class II

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 913225f0-b276-4e83-98d9-c223208d1740 34 fields · synced Jun 6, 2026