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
05060267134547FORCECORDXIROS LTDOJH2026-07-06
10198956182004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956373068CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956407053CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956414693CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956428881CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956429901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956457775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956474895CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956481015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956484177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956490833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956491038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492158CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492196CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494572CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956497498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498426CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956499775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503199CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503298CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956508798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956509368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956512962CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956513921CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956516571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956518018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956525597CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06