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Halyard

FDA UDI

Class II (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
Halyard FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
HALYARD BASICS* Shoulder Arthroscopy Pack I FDA UDI
Model / Reference
88888 FDA UDI
Description
HALYARD BASICS* Shoulder Arthroscopy Pack I FDA UDI

Identifiers

Catalog Number
88888 FDA UDI
Primary DI / UDI-DI
10680651888881 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
General 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Halyard by O&M Halyard, 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O&M Halyard, Inc.

Sources (1)

  • FDA UDI 5a5db114-e2d3-462a-8b63-81fcb23b9463 35 fields · synced May 31, 2026