FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143901153
Brand
SURGIPROS
Company
Surgipros, LLC
Model
102906SP
Device description
WRENCH EXTENDED HANDLE 13MM OPEN/BOX END
Published
2023-09-08
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
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143901153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143901153008101439011538101439011530810143901153

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4109600452info@surgipros.com

Regulatory Flags#

DUNS number
058689193
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143904666SURGIPROS80-1100SP2026-06-01
00810143904673SURGIPROS80-1102SP2026-06-01
00810143905809SURGIPROS85-1608SP2026-06-01
00810143905816SURGIPROS85-1610SP2026-06-01
00810143905823SURGIPROS85-1612SP2026-06-01
00810143905830SURGIPROS85-1614SP2026-06-01
00810143905847SURGIPROS85-1616SP2026-06-01
00810143905854SURGIPROS85-1618SP2026-06-01
00810143905861SURGIPROS85-1620SP2026-06-01
00810143905878SURGIPROS85-1622SP2026-06-01
00810143905885SURGIPROS85-1624SP2026-06-01
00810143905892SURGIPROS85-1626SP2026-06-01
00810143905908SURGIPROS85-1628SP2026-06-01
00810143905915SURGIPROS85-1630SP2026-06-01
00810143907261SURGIPROSFL101SP2026-06-01
00810143907278SURGIPROSFL102SP2026-06-01
00810143907308SURGIPROSFL108SP2026-06-01
00810143907315SURGIPROSFL109SP2026-06-01
00810143908329SURGIPROSBC924SP2026-06-01
00810212930008SURGIPROSOS-1/4SP2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B756007053001000Torque WrenchShukla MedicalHXC2026-06-01
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
00841732144309GENERIC Surgical InstrumentsCTL Medical CorporationHXC2023-09-15
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
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B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380240Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380260Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380300Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380420Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380600Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380820Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380830Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380840Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380850Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28