FDA.reportPublic FDA data

Schaerer Medical USA

Primary DI
00810101300684
Brand
Schaerer Medical USA
Company
Schaerer Medical Usa, Inc.
Model
528-0148-03
Catalog number
528-0148-03
Device description
"55"" IA BOARD PAD 3"" "
Published
2022-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810101300684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810101300684008101013006848101013006840810101300684

GMDN Terms#

Term, Definition table
TermDefinition
Operating table torso positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Inch
Length55Inch

Contacts#

Phone, Email table
PhoneEmail
1-800-755-6381customerservice@schaerermedicalusa.com

Regulatory Flags#

DUNS number
092820703
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810101300261Schaerer Medical USA71077710772022-09-16
10810101300506Schaerer Medical USA10940109402022-09-16
10810101300551Schaerer Medical USA10820108202022-09-16
00810101300080Schaerer Medical USA10823108232022-09-16
00810101300127Schaerer Medical USA10830108302022-09-16
00810101300141Schaerer Medical USA10908109082022-09-16
00810101300189Schaerer Medical USA22111221112022-09-16
00810101300202Schaerer Medical USA529-0715-00529-0715-002022-09-16
00810101300318Schaerer Medical USA73002730022022-09-16
00810101300356Schaerer Medical USA73013730132022-09-16
00810101300387Schaerer Medical USA73020730202022-09-16
00810101300592Schaerer Medical USA528-0128-00528-0128-002022-09-16
00810101300646Schaerer Medical USA528-0134-00528-0134-002022-09-16
00810101300653Schaerer Medical USA528-0134-03528-0134-032022-09-16
00810101300721Schaerer Medical USA528-0150-00528-0150-002022-09-16
00810101300738Schaerer Medical USA528-0150-03528-0150-032022-09-16
00810101300745Schaerer Medical USA528-0151-00528-0151-002022-09-16
00810101300790Schaerer Medical USA528-0162-00528-0162-002022-09-16
00810101300820Schaerer Medical USA528-0213-03528-0213-032022-09-16
00810101300899Schaerer Medical USA6960-36960-32022-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008370MorphBoard®Innovative Medical Products, IncFWZ2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
00696588008318De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
07640152573989FISSOBaitella AGFWZ2025-10-13
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28
00615521032203ALLENHILL-ROM, INC.FWZ2023-06-02
00615521015299ALLENHILL-ROM, INC.FWZ2023-05-31
00615521014476ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30