Aqualgel

AQUAGEL Sacral Protector, Small is a 3-dimensional positioner that re-distributes pressure away from the sacrum and is ideal for all supine patients, especially those in the Lithotomy…

Registry build 21.09.26

AQUAGEL Sacral Protector, Small is a 3-dimensional positioner that re-distributes pressure away from the sacrum and is ideal for all supine patients, especially those in the Lithotomy position.

4manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (3), Jiangsu (1).

Chinese manufacturers registered for FDA product code LWG
Manufacturer City Province Registered as Device types
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Shijiazhuang Aofeite Medical Device Co., Ltd. Shijiazhuang Hebei Manufacturer 28
Hebei Webian Medical Instrument Trading Co., Ltd. Shijiazhuang Hebei Manufacturer 14
HI-Life Technology (Hebei) Co., Ltd. Bazhou Hebei Manufacturer 11

Record

Regulatory record for Aqualgel
Listed by Steris Corporation, United States
FDA product code LWG
Device type Surgical Table Cushion
Device class Class 1
Regulation 21 CFR 878.4950
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-12-01
Record revised 2025-03-18 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date
Storage Storage environment temperature -18 to 50 °C

Catalogue Numbers

Catalogue numbers for Aqualgel
Catalogue number Size Per pack Status
BF473 In distribution
BF481 In distribution
BF478 In distribution
BF488 In distribution
BF475 In distribution
BF474 In distribution
BF489 In distribution
BF463 In distribution
BF477 2 In distribution
BF476 In distribution
BF487 In distribution
BF486 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Birkova Steris Corporation 455
Rayshield Aadco Medical, Inc. 381
Coulmed Coulmed Products Group LLC 343
Skytron Skytron, LLC 307
Aadco Aadco Medical, Inc. 267
Surgical Table Cushion Steris Corporation 265
XcelGel Polymer Concepts, Inc. 211
Tablepad Burlington Medical, LLC 145
Surgical Table Cushion David Scott Company. 107
Prime Medical LLC Prime Medical, Inc. 81
C-Matt Casco Manufacturing Solutions, Inc. 68
Operon Stryker Communications, Inc. 31

Showing 12 of 369. All products under Surgical Table Cushion

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer