FDA.reportPublic FDA data

MaxBraid Suture BroadBand Tape (Basic)

Primary DI
00840277401373
Brand
MaxBraid Suture BroadBand Tape (Basic)
Company
RIVERPOINT MEDICAL, LLC
Model
110046602
Device description
Subscapularis Repair Suture Kit-Basic (Suture Kit - KIT703 is convenience kit containing HS Fiber sutures (K190817; K153307) and Drill Bit (HTW, 510k exempt)).
Published
2022-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVNSuture Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277401373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277401373008402774013738402774013730840277401373

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964053560
Device count
1
Premarket exempt
true
Kit
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
00840277401397MaxBraid Suture BroadBand Tape (Ultra)1100464552022-07-27
00840277411105Native Root500.0002026-05-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09
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10198956318380CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
10198956325135CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
10198956252134CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
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10198956285712CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
10198956249868CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956192966CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
10198956199620CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956279797CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956233522CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
10198956219205CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956223288CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956187450CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-03
10198956185128CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
10198956192881CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22