← Back to catalogue

Medline Industries, Inc.

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline Industries, Inc. FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
PEDIATRIC ENDO KIT FDA UDI
Model / Reference
DYKE1348 FDA UDI
Description
PEDIATRIC ENDO KIT FDA UDI

Identifiers

Catalog Number
DYKE1348 FDA UDI
Primary DI / UDI-DI
10889942262632 FDA UDI
510(k) Number
K913500 FDA UDI
FDA Product Code
GCJ 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
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Medline Industries, Inc. by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K913500 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 25887576-2ee7-4e34-a651-a99d27ef7972 36 fields · synced Jun 8, 2026