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Hcs

FDA UDI

Class I (US FDA UDI)

by Concordance Healthcare Solutions LLC

Identity

Trade Name
HCS FDA UDI
Generic Name
Surgical patient underpants FDA UDI
Device Name
Ortho Shorts, Single Use, Blue, SMS, Medium, Latex Free FDA UDI
Model / Reference
HCS4001 FDA UDI
Description
Ortho Shorts, Single Use, Blue, SMS, Medium, Latex Free FDA UDI

Identifiers

Primary DI / UDI-DI
00810132040979 FDA UDI
FDA Product Code
OEA FDA UDI
GMDN Term
Surgical patient underpants FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical patient underpants

Hcs by Concordance Healthcare Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical patient underpants.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Concordance Healthcare Solutions LLC

Sources (1)

  • FDA UDI 999da742-6880-4ad5-b9d9-19443409e208 33 fields · synced Jun 8, 2026