FDA.reportPublic FDA data

Mini and Micro Fragments Reconstruction System - GMReis

Primary DI
07899258696898
Brand
Mini and Micro Fragments Reconstruction System - GMReis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
VERSALOCK WATERSHED VOLAR PLATE - 68,0X23,0MM, RIG
Catalog number
180-176-D
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258696898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258696898078992586968987899258696898

GMDN Terms#

Term, Definition table
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, and may be used in connection with another fixation plate; 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 table
Method
Moist Heat or Steam Sterilization

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
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
07899258695846Meniscus VersaflexMeniscus Versaflex354-3002026-03-03
07901125601062Meniscus VersaflexMeniscus Versaflex - Reverse354-4002026-03-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
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07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
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00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23