ForceFlex

Primary DI
10810020085478
Brand
ForceFlex
Company
RIVERPOINT MEDICAL, LLC
Model
SS642
Device description
Suture
Published
2022-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020085478PackageGS112In Commercial Distribution
00810020085471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008547810810020085478
00810020085471008100200854718100200854710810020085471

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964053560
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00840277404992OsseoFitâ„¢ Subscapularis Kit (Suture Anchor)1200020502024-12-31
00840277405005OsseoFitâ„¢ 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810020085464ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085471ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085488ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085495ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085501ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085518ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085525ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085532ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085549ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085556ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085563ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085570ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085587ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085594ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085600ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085617ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085624ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085631ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085648ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085655ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085662ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085679ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
00810020085686ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085461ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085485ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085492ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085508ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085515ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085522ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29
10810020085539ForceFlexRIVERPOINT MEDICAL, LLCPTX2022-06-29