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Steri-Shield

FDA UDI

Class I (US FDA UDI)

by Steri-Shield Products, Inc.

Identity

Trade Name
Steri-Shield FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
Curelastic (sm/med), Non-latex, Case FDA UDI
Model / Reference
088-065 FDA UDI
Description
Curelastic (sm/med), Non-latex, Case FDA UDI

Identifiers

Primary DI / UDI-DI
10850040097051 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment/instrument drape, single-use

Steri-Shield by Steri-Shield Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment/instrument drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 2ca9be01-bef6-41f1-9a19-6bc27766478a 33 fields · synced Jun 6, 2026