FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143901177
Brand
SURGIPROS
Company
Surgipros, LLC
Model
102911SP
Device description
FIXATION BOLT WRENCH 10MM
Published
2023-09-08
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
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143901177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143901177008101439011778101439011770810143901177

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143905779SURGIPROSWR412S2026-05-23
00810143907032SURGIPROSBC171SP2026-05-23
00810143907483SURGIPROSBC173SP2026-05-23
00810143907490SURGIPROS5005-44SP2026-05-23
00810143907537SURGIPROSBF113SP2026-05-23
00810212930374SURGIPROSBC181SP2026-05-23
00810212930480SURGIPROSBT041T2026-05-22
00810212930497SURGIPROSFB882SP2026-05-22
00810212930510SURGIPROS50-4681SP2026-05-22
00810212930534SURGIPROS50-4680SP2026-05-22
00810212930664SURGIPROSBC915SP2026-05-23
00810212930671SURGIPROSBC919SP2026-05-23
00810212930725SURGIPROSBC924SP2026-05-23
00810212931340SURGIPROSFB402T2026-05-22
00810212933054SURGIPROSEA016T2026-05-22
00810143905052SURGIPROS7803-65SP2024-09-18
00810143905113SURGIPROS9009-13SP2024-09-18
00810143905120SURGIPROS9009-14SP2024-09-18
00810143905137SURGIPROS3092SP2024-09-18
00810143905144SURGIPROS3099SP2024-09-18

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Primary DI, Brand, Company table
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00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
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03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
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00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
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03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
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00840314269768gSourceGSOURCE LLCHXC2025-08-29
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00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26