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Strong Manufacturers

FDA UDI

Class I (US FDA UDI)

by Strong Medical Partners LLC

Identity

Trade Name
Strong Manufacturers FDA UDI
Generic Name
Shoe cover FDA UDI
Device Name
Shoe Covers, Blue, Universal Size, case of 300 ea, non-conductive, non-skid surface FDA UDI
Model / Reference
5101 FDA UDI
Description
Shoe Covers, Blue, Universal Size, case of 300 ea, non-conductive, non-skid surface FDA UDI

Identifiers

Catalog Number
5101 FDA UDI
Primary DI / UDI-DI
00853927007672 FDA UDI
FDA Product Code
FXP FDA UDI
GMDN Term
Shoe cover 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

Yes

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: Shoe cover

Strong Manufacturers by Strong Medical Partners LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoe cover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI aa08495d-3a38-4368-a468-7386a5adb871 36 fields · synced Jun 1, 2026