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Sterimed

FDA UDI

Class II (US FDA UDI)

by Sterimed, Inc.

Identity

Trade Name
Sterimed FDA UDI
Generic Name
X-ray system cover FDA UDI
Device Name
3 Piece C-Arm Cover Pack (1 - 9" X 70" Drape, 2 - 36" X 25" Band Bags) FDA UDI
Model / Reference
0587W-1 FDA UDI
Description
3 Piece C-Arm Cover Pack (1 - 9" X 70" Drape, 2 - 36" X 25" Band Bags) FDA UDI

Identifiers

Primary DI / UDI-DI
00850341007851 FDA UDI
510(k) Number
K853044 FDA UDI
FDA Product Code
IZI FDA UDI
GMDN Term
X-ray system cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1600 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

Yes

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: X-ray system cover

Sterimed by Sterimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray system cover.

Cleared under the same submission

K853044 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterimed, Inc.

Sources (1)

  • FDA UDI d329f1d0-f4a0-419a-8396-05e74d86385b 35 fields · synced May 31, 2026