FDA.reportPublic FDA data

Schaerer Medical USA

Primary DI
10810101300551
Brand
Schaerer Medical USA
Company
Schaerer Medical Usa, Inc.
Model
10820
Catalog number
10820
Device description
Table Cushion Set
Published
2022-09-16
Public version status
Update
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
10810101300551PrimaryGS10
00810101300554Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010130055110810101300551
00810101300554008101013005548101013005540810101300554

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extension, non-poweredA non-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar).

Contacts#

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

Regulatory Flags#

DUNS number
092820703
Device count
5
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
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
00810101300905Schaerer Medical USA6962-36962-32022-09-16

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Primary DI, Brand, Company table
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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