FDA.reportPublic FDA data

SchureMed

Primary DI
00810014603407
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
790-0057
Device description
SCHURELOC XPS COUNTER TRACTION POST
Published
2020-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810014603407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014603407008100146034078100146034070810014603407

GMDN Terms#

Term, Definition table
TermDefinition
Surgical counter-traction postA cylindrical rod designed to be attached to an operating table or extension device to function as a support to counter the pulling of the traction being applied to a patient's body part (e.g., leg, pelvis) during an orthopaedic surgical procedure (e.g., hip arthroplasty, pelvic reconstruction); it is typically placed against the perineal region [referred to as perineal post] or leg bones (e.g., femur, tibia). It is available in various diameters and lengths and is typically padded. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(781)982-7000Lisa@SchureMed.com

Regulatory Flags#

DUNS number
964322929
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00810014601946SchureMed800-0142-SKY3-040-302019-06-13
00810014602974SchureMed800-0164-SKY3-040-33-12019-06-13
00810057373138SchureMed508-15402021-09-22
00810057373794SchureMed800-0142-S-EU2021-09-10
00810014602912SchureMed800-00062021-09-02
00810014603605SchureMed508-0373508-03732021-09-02
00810057371578SchureMed790-0079-N2021-09-02
00810057373787SchureMed800-0142-S2021-09-02
00841036239640SchureMed800-0134-Z2021-09-02
00810014604466SchureMed508-00912020-10-05
00081005737313SchureMed508-15402021-08-12
00810014601137SchureMed800-02802021-08-12
00810014601816SchureMed800-01002021-08-12
00810014602226SchureMed800-0280-DEN2021-08-12
00810014603483SchureMed800-0125-EU2021-08-12
00810014603506SchureMed800-01252021-08-12
00810057371615SchureMed990-00502021-08-12
00810057371622SchureMed990-0050-OEM2021-08-12
00810057371639SchureMed990-0050-HD2021-08-12
00810057371646SchureMed990-0050-R2021-08-12

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Primary DI, Brand, Company table
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20653405990182CONMEDConmed CorporationFWZ2026-01-17
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00724995245016ClampSTERIS CORPORATIONFWZ2025-05-05
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