FDA.reportPublic FDA data

Native Root

Primary DI
00840277411112
Brand
Native Root
Company
RIVERPOINT MEDICAL, LLC
Model
501.000
Device description
Orthopedic Kit
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277411112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277411112008402774111128402774111120840277411112

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
964053560
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277412065ViletV6182026-06-08
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
00840277404992OsseoFit™ Subscapularis Kit (Suture Anchor)1200020502024-12-31
00840277405005OsseoFit™ Subscapularis Kit (Bone Tunnel)1200020512024-12-31
00840277401380Fracture Repair Suture Kit1100464562022-11-04
00840277401403Open Soft Tissue Repair Suture Kit-Small3910-900-1452022-11-04
00840277401410Open Soft Tissue Repair Suture Kit-Large3910-900-1462022-11-04
00840277401373MaxBraid Suture BroadBand Tape (Basic)1100466022022-07-27
00840277401397MaxBraid Suture BroadBand Tape (Ultra)1100464552022-07-27
00840277411105Native Root500.0002026-05-06
00840277412034No-Tie Button101.0002026-05-06
00810020082982HS FiberHS2312020-03-04
00810020082999HS FiberHS2322020-03-04
00812444026726HS SUTURE TAPEHS2092017-07-19
00812444026757HS SUTURE TAPEHS2112017-07-19
00810020083491HS FiberHS3392026-04-23
00840277411433SutUpHS156-MU2026-04-14
00840277411440SutUpHS519-MU2026-04-14
00840277411457SutUpHS1062-MU2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS189110Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-26
B098AMS193930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-26
B098AMS17809A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-22
10809160527603HALYARDAVID MEDICAL, INC.OJH2026-07-21
10198956180222CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956282360CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956291836CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956301573CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956307438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956316515CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956338326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956362208CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370456CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370982CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956372559CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956378421CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956379077CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956383302CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956387201CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956391673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956392823CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956402676CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956416116CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956422506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956440869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956442290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956455115CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956461994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20