← Back to catalogue

MeroPack™

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
MeroPack™ FDA UDI
Generic Name
ENT space-occupying dressing, animal-derived FDA UDI
Device Name
DRESSING 1520000 MEROPACK 6PK FDA UDI
Model / Reference
1520000 FDA UDI
Description
DRESSING 1520000 MEROPACK 6PK FDA UDI

Identifiers

Primary DI / UDI-DI
20885074137777 FDA UDI
510(k) Number
K041381 FDA UDI
FDA Product Code
LYA FDA UDI
GMDN Term
ENT space-occupying dressing, animal-derived FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ENT space-occupying dressing, animal-derived

MeroPack™ by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT space-occupying dressing, animal-derived.

Cleared under the same submission

K041381 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
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI dc2064c7-089e-4bbf-89a6-73c6c70ac7be 36 fields · synced May 31, 2026