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450p

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
450P FDA UDI
Generic Name
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
KIT INTERNATIONAL PAL 450P FDA UDI
Model / Reference
72200101 FDA UDI
Description
KIT INTERNATIONAL PAL 450P FDA UDI

Identifiers

Catalog Number
72200101 FDA UDI
Primary DI / UDI-DI
03596010542199 FDA UDI
510(k) Number
K031379 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laparoscopic surgical procedure kit, non-medicated, single-use

450p by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K031379 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI a5681995-663c-45ea-ae0d-c4d33a77e658 36 fields · synced Jun 8, 2026