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Ever-Soft Positioning Wedge

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Ever-Soft Positioning Wedge FDA UDI
Generic Name
Assistive sleeping cushion set FDA UDI
Device Name
Positioning Wedge 8"x8"x24", 45 Degrees FDA UDI
Model / Reference
13001 FDA UDI
Description
Positioning Wedge 8"x8"x24", 45 Degrees FDA UDI

Identifiers

Primary DI / UDI-DI
00840117307728 FDA UDI
FDA Product Code
IMP FDA UDI
GMDN Term
Assistive sleeping cushion set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Assistive sleeping cushion set

Ever-Soft Positioning Wedge by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assistive sleeping cushion set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI f88d7f84-5897-4f71-9b0d-82ec3d52a2c6 33 fields · synced Jun 8, 2026