FDA.reportPublic FDA data

GMReis Suture Anchors

Primary DI
07901125601130
Brand
GMReis Suture Anchors
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
FASTLOCK - KNOTLESS PEEK ANCHOR Ø4.75x15.0/19.1mm
Catalog number
320-475191-PE3H
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07901125601130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07901125601130079011256011307901125601130

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258616506Orthopedic InstrumentsSYNDESMOSIS CLAMP314-1002026-07-07
07899258625348Orthopedic InstrumentsGUIDE WIRE Ø1.0x190.0mm WITHOUT THREAD106-812026-07-07
07899258625355Orthopedic Instruments1,0x190mm THREADED GUIDE WIRE106-822026-07-07
07899258633350Orthopedic InstrumentsGUIDE DRILL DOUBLE 2,7mm106-852026-07-07
07899258633367Orthopedic Instruments4.0mm CANCELLOUS TAP106-862026-07-07
07899258633374Orthopedic InstrumentsSMALL DEPTH GAUGE106-872026-07-07
07899258633381Orthopedic InstrumentsØ1.0x250.0mm WIRE106-882026-07-07
07899258634388Orthopedic InstrumentsSCREW EXTRACTOR 3.5mm169-4252026-07-07
07899258636290Orthopedic InstrumentsØ3.2mm WIRE CUTTING FORCEPS172-19A2026-07-07
07899258645094Orthopedic InstrumentsSCREW DRIVER TIP HEXALOBULAR T15 FIT AO307-1102026-07-07
07899258646527Orthopedic Instruments1.0x20.0x100.0mm GUIDE WIRE WITH SPHERICAL STOP223-3062026-07-07
07899258655864Orthopedic InstrumentsINSTRUMENTAL TRAY FOR ANKLE FRACTURE314-70022026-07-07
07899258655871Orthopedic InstrumentsIMPLANT TRAY TO ANKLE FRACTURE314-70042026-07-07
07899258655932Orthopedic InstrumentsVERSALOCK SYSTEM KIT FOR ANKLE314-70012026-07-07
07899258655949Orthopedic InstrumentsANKLE FRACTURE IMPLANT TRAY314-70032026-07-07
07899258656151Orthopedic InstrumentsIDENTIFICATION AND ORIENTATION PANEL314-70082026-07-07
07899258695464Orthopedic InstrumentsVERSA AND VERSALOCK SCREW CASES Ø2.7mm AND Ø3.5mm314-70052026-07-07
07899258695471Orthopedic InstrumentsMINI CANNULATED SCREW CASE Ø4.0mm AND DEDICATED IN314-70062026-07-07
07899258695488Orthopedic InstrumentsVERSALOCK MINI PLATE CASE314-70072026-07-07
07899258602042Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø1.8mm180-3902026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
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