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Single Incision Kit

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
SINGLE INCISION KIT FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM FDA UDI
Model / Reference
CK400 FDA UDI
Description
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM FDA UDI

Identifiers

Primary DI / UDI-DI
30607915130924 FDA UDI
FDA Product Code
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, single-use 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ligation clip, metallicLaparoscopic multi-instrument access port, single-use

Single Incision Kit by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI 30ddce61-e4cc-4270-b93b-5c0daa4c7ca9 34 fields · synced Jun 1, 2026