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Merit Medical®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit Medical® FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
00884450471111 FDA UDI

Identifiers

Primary DI / UDI-DI
00884450471111 FDA UDI
FDA Product Code
OEQ FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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

Yes

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

Merit Medical's General Surgical Procedure Kit is a single-use, non-medicated device designed for use in open abdominal surgery, minor dermatological procedures, and cosmetic surgery. It includes a range of surgical instruments and materials intended to aid in preparation and scrubbing during these procedures without the need for pharmaceuticals or sterile equipment.

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
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 5d1ec4d6-5976-4898-b075-14af62718f45 32 fields · synced Oct 6, 2026