FDA.reportPublic FDA data

Schaerer Medical USA

Primary DI
00810101300509
Brand
Schaerer Medical USA
Company
Schaerer Medical Usa, Inc.
Model
10940
Catalog number
10940
Device description
TRACTION BOOT SOCK INSERT
Published
2022-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEBTable, Surgical With Orthopedic Accessories, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEBTable, Surgical With Orthopedic Accessories, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810101300506PrimaryGS10
00810101300509Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010130050610810101300506
00810101300509008101013005098101013005090810101300509

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
092820703
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00840536822543Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822550Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822567Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822574Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822581Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822598Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822604Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822611Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822628Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822635Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822642Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
04251732800383X-Ray Top Seat section PST 500Jörg & Sohn GmbHJEB2026-05-18
04251732800406X-Ray Top Back section PST 500 UJörg & Sohn GmbHJEB2026-05-18
04251732800413Cart for X-Ray TopsJörg & Sohn GmbHJEB2026-05-18
04251732800420Pad leg section light high H GJörg & Sohn GmbHJEB2026-05-18
04251732800437Clamshell Armboard PadJörg & Sohn GmbHJEB2026-05-18
00190776418670MillenniumAvalign Technologies, Inc.JEB2026-04-09
04251732800338X-Ray Top Head sectionJörg & Sohn GmbHJEB2025-06-26
04251732800345X-Ray Top Back section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800352X-Ray Top Seat section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800369X-Ray Top Universal sectionJörg & Sohn GmbHJEB2025-06-26
04251732800376X-Ray Top Leg section one partJörg & Sohn GmbHJEB2025-06-26
G611BIO110210Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110220Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110230Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110240Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024B0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024C0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110310Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110320Alliant BiotechMEDISURGE LLCJEB2024-08-16