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Hyh

FDA UDI

Class II (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
HYH FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
OB PACK III FDA UDI
Model / Reference
88831 FDA UDI
Description
OB PACK III FDA UDI

Identifiers

Primary DI / UDI-DI
10680651888317 FDA UDI
510(k) Number
K083234 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

Hyh 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.

Cleared under the same submission

K083234 also covers:

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 6c9e0a18-7709-43ad-aab6-5a36d2f76ecb 35 fields · synced May 30, 2026