← Back to catalogue

Merit Medical®

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit Medical® FDA UDI
Generic Name
Procedural medication labelling set FDA UDI
Model / Reference
00884450186992 FDA UDI

Identifiers

Catalog Number
K13-00523 FDA UDI
Primary DI / UDI-DI
00884450186992 FDA UDI
FDA Product Code
PYB FDA UDI
GMDN Term
Procedural medication labelling set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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: Procedural medication labelling set

Merit Medical's Minor Surgical Procedures Tray is a comprehensive procedural medication labeling set designed for general, plastic surgery procedures. The tray includes a permanent marking pen and various labels made of moisture-resistant plastic material with standard medication/drug/solution text.

Similar devices

Also classified as Procedural medication labelling set.

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

Sources (1)

  • FDA UDI 9a4da46b-5674-4edc-bced-516050a6370e 33 fields · synced Jul 25, 2026