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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
PACK,LITHOTOMY,PK IV,AURORA FDA UDI
Model / Reference
DYNJP9030A FDA UDI
Description
PACK,LITHOTOMY,PK IV,AURORA FDA UDI

Identifiers

Catalog Number
DYNJP9030A FDA UDI
Primary DI / UDI-DI
10080196915392 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Medline by Medline Industries, 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI a23a2824-9db5-4d15-a727-80f0e627c4ce 35 fields · synced Jun 6, 2026