← Back to catalogue

Aqualgel

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name
AQUALGEL FDA UDI
Generic Name
Heel stirrup cushion/pad, reusable FDA UDI
Device Name
AQUAGEL Heel Protector are 3-dimensional and provide heel protection and positioning stability. FDA UDI
Model / Reference
BF477 FDA UDI
Description
AQUAGEL Heel Protector are 3-dimensional and provide heel protection and positioning stability. FDA UDI

Identifiers

Catalog Number
BF477 FDA UDI
Primary DI / UDI-DI
10724995219953 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Heel stirrup cushion/pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Heel stirrup cushion/pad, reusable

Aqualgel by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heel stirrup cushion/pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI d13a716a-988f-4107-85be-4a4304637998 36 fields · synced Jun 8, 2026