FDA.report

Quick - Radius Disposable Set

Primary DI
07899258659602
Brand
Quick - Radius Disposable Set
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Versalock Screw Ti T7
Catalog number
223-24-10-BPS
Device description
Versalock Screw Ti T7
Published
2024-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K231684000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231684000Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.2024-01-12HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258659602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899258659602078992586596027899258659602

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods

Method

Regulatory Flags

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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07899258602011Orthopedic InstrumentsTHREADED OLIVE WIRE Ø1.2x60.0mm308-9152026-02-26
07901125601079Orthopedic InstrumentsCASE - COMPRESSION PLATES IMPLANTS AND INSTRUMENTS308-ES-FU2026-02-26
07899258602028Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø1,5MM308-9032026-02-20
07899258602035Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø2,0MM308-9092026-02-20
07899258638973Orthopedic InstrumentsBACAUS CANNULATED FORCEPS900-1502026-02-20
07899258639062Orthopedic InstrumentsPeriostum 4.0mm Straight Tip900-992026-02-20
07899258648057Orthopedic InstrumentsHOHMANN SEPARATOR 8.0mm900-1012026-02-20
07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
07899258660929Orthopedic InstrumentsHex wrench 4.0353-109-10352026-02-20
07899258660936Orthopedic Instruments3.5 hex wrench353-109-10362026-02-20
07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
07899258660950Orthopedic Instruments2.5 Hex Wrench353-109-10382026-02-20
07899258660967Orthopedic InstrumentsHex wrench 2.0353-109-10392026-02-20
07899258660974Orthopedic InstrumentsHex wrench 1.5353-109-10402026-02-20
07899258660981Orthopedic Instruments5.0 Hex wrench353-109-10332026-02-20
07899258660998Orthopedic Instruments5.5 Hex Wrench353-109-10322026-02-20
07899258694702Orthopedic InstrumentsTorxdrive Wrench T20353-109-10222026-02-20
07899258694719Orthopedic InstrumentsTorxdrive Wrench T18353-109-10232026-02-20

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