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Alexis Laparoscopic System With Kii Fios First Entry

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
Alexis Laparoscopic System With Kii Fios First Entry FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Laparoscopic Access System FDA UDI
Model / Reference
C8702 FDA UDI
Description
Laparoscopic Access System FDA UDI

Identifiers

Primary DI / UDI-DI
00607915125721 FDA UDI
FDA Product Code
GCJ FDA UDI
KKX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.4370 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

No

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: General surgical procedure kit, non-medicated, single-use

Alexis Laparoscopic System With Kii Fios First Entry by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General surgical procedure kit, non-medicated, 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 de6a8812-09c2-4e5a-a837-ac7b33ad3f8b 35 fields · synced May 30, 2026