FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXCWrench

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810143901153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143901153008101439011538101439011530810143901153

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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00810212930534SURGIPROS50-4680SP2026-05-22
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00810212930671SURGIPROSBC919SP2026-05-23
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00810143905137SURGIPROS3092SP2024-09-18
00810143905144SURGIPROS3099SP2024-09-18

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