FDA.reportPublic FDA data

Native Root

Primary DI
00840277411105
Brand
Native Root
Company
RIVERPOINT MEDICAL, LLC
Model
500.000
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
00840277411105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277411105008402774111058402774111050840277411105

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
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
00840277411112Native Root501.0002026-05-06
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
00840277412041SutUpHS959-MU2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10193489203493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489212884Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489213737Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213911Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489213966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489214130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214406Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214499Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214697Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215465Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489216165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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