BoneFoam

Jon Urology Bolsters (Pair of Bolsters) - Box of 5 pairs

Registry build 21.09.26
66manufacturers in China registered for this device type
93catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (16), Guangdong (11). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CCX
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Jinhua Ivy Home Textile Co., Limited Jinhua Zhejiang Contract manufacturer 18
Shenzhen Zhouyang Medical Care Product Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17
Jiangsu Classic NEW-Type Medical Products Co., Ltd. Yancheng Jiangsu Contract manufacturer 13
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 66. All 66 manufacturers in China registered for Support, Patient Position

Record

Regulatory record for BoneFoam
Listed by Bone Foam Inc., United States
FDA product code CCX
Device type Support, Patient Position
Device class Class 1
Regulation 21 CFR 868.6820
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-05-22
Record revised 2026-06-12 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number
Sizes Length 18.6 to 42 in; height 4 to 19.32 in; width 6 to 23.5 in; outer diameter 3.5 to 9 in
Distribution end date 2022-07-07

Catalogue Numbers

Catalogue numbers for BoneFoam
Catalogue number Size Per pack Status
925.LW Length 33 in In distribution
925.LUEWL Length 24 in In distribution
925.PTR Height 6 in In distribution
925.UPS-R-UB Height 5.75 in In distribution
925.UPS-L-UB Height 6.75 in In distribution
925.ABCUT In distribution
925.MTO-D In distribution
925.SCTR Length 30 in In distribution
104.NPS-SB In distribution
925.AAKWL Height 19.32 in In distribution
925.AAKWS Width 11 in In distribution
925.PROP-L-BX5 Length 25.75 in 5 In distribution
925.TR Height 6 in In distribution
925.AAKWM Height 17.28 in In distribution
10-911-06-C In distribution
925.SHARK-S-WS Height 13 in In distribution
925.HIPPY In distribution
104.SLPS-AB In distribution
104.LHS-BX10 10 In distribution
925.GULLY In distribution
104.NPSB In distribution
925.PC In distribution
925.SAS-WS-BX10 10 In distribution
10-910-06-C In distribution
104.NPLB In distribution
925.MBR Length 22.75 in In distribution
925.HIPPY-PPBP-L Outer Diameter 4.5 in In distribution
925.LWS Length 24 in In distribution
925.ULT2-WS Length 31.25 in In distribution
925.HIPPY-TB In distribution
10-910-13-C-I In distribution
925.JUB 5 In distribution
10-910-02 4 In distribution
925.MBS Width 22 in In distribution
925.UPS-S-LB Height 5.75 in In distribution
925.RUEWL Length 24 in In distribution
925.LLB-BX5 5 In distribution
925.PULT2-WS Length 24.5 in In distribution
104.SLPS-TB In distribution
925.MTO-C In distribution
925.HIPPY-LEP In distribution
925.5CB Outer Diameter 5 in In distribution
925.UEBS Width 6 in In distribution
925.LLT2-WS In distribution
925.HIPPY-BP In distribution
925.PSCTR Height 4 in In distribution
925.9CB Outer Diameter 9 in In distribution
10-910-01-C In distribution
925.PROPC-L Length 25.75 in In distribution
104.NPL In distribution
925.LUEWS Height 10 in In distribution
925.MBL Width 15 in In distribution
10-910-00 3 In distribution
925.7CB Outer Diameter 7 in In distribution
925.UEBL Width 8 in In distribution
925.RUEWS Length 19.5 in In distribution
925.OAKWS Height 10.14 in In distribution
104.NPS-TB In distribution
925.UUELW In distribution
10-911-07-C In distribution
925.HIPPY-PPBP-S Outer Diameter 3.5 in In distribution
925.ABD-BX10 10 In distribution
925.LC In distribution
925.OAKWL Length 27 in In distribution
925.TRS Length 23 in In distribution
925.UPS-L Height 6.75 in In distribution
104.NPS-TA In distribution
925.DR In distribution
925.UPS-L-LB Height 6.75 in In distribution
925.UPS-R Height 5.75 in In distribution
925.HIPPY-LB In distribution
925.UPS-S Height 5.75 in In distribution
925.HIPPY-HB In distribution
925.PROPC-R Width 14.5 in In distribution
925.UPS-S-UB Height 5.75 in In distribution
104.SLPS-HB In distribution
925.SER In distribution
925.SHARK-WS Height 15.5 in In distribution
10-910-02-C 4 In distribution
10-910-07-C 2 In distribution
925.EH In distribution
925.UPS-R-LB Height 5.75 in In distribution
925.TRPP2 In distribution
925.DLS-WS In distribution
104.SLPS-LB In distribution
925.KB In distribution
925.SG-BX10 10 In distribution
925.RLT2-WS In distribution
925.PROP-R-BX5 Width 14.5 in 5 In distribution
925.KBEX-C In distribution
10-910-12-C-I In distribution
925.SAS-BX10 10 Withdrawn
925.LLB-BX10 10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 225
Soule Medical Soule Co., THE 212
Coulmed Coulmed Products Group LLC 135
Techno-Aide Techno-Aide, Inc. 108
Halyard Owens & Minor Distribution, Inc. 80
Devon Cardinal Health 75
Domico Med-Device Domico Med-Device, LLC 69
Universal Lateral Positioner® Innovative Medical Products, Inc. 69
Lateral Patient Positioning System Alphatec Spine, Inc. 65
Cardinal Health Cardinal Health 200, LLC 64
Pediatric Patient Positioner Alphatec Spine, Inc. 55
Support, Patient Position David Scott Company. 51

Showing 12 of 1,485. All products under Support, Patient Position

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