FDA.reportPublic FDA data

Mono Q®

Primary DI
10810020088813
Brand
Mono Q®
Company
RIVERPOINT MEDICAL, LLC
Model
Q1420
Device description
Suture.
Published
2022-06-28
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020088813PackageGS112In Commercial Distribution
00810020088816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008881310810020088813
00810020088816008100200888168100200888160810020088816

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964053560
Device count
1
DM exempt
false
Premarket exempt
false
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
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
00840277405609LigaMend™ (Black)102.0002026-03-19
00840277405616LigaMend™ (Blue)112.0002026-03-19
00840277405623LigaMend™105.0002026-03-19
00840277405630Strut Suture103.0002026-03-19
00840277405715LigaMend™ Soft Button (Black)106.0002026-03-19
00840277405722LigaMend™ Soft Button (Blue)116.0002026-03-19
00840277411358No-Tie Button111.0002026-03-19
10810020085218HS FiberHS1652026-03-16
10840277411768HS FiberHS2412026-03-16
10840277411775HS FiberHS2422026-03-16
10840277411782HS FiberHS2432026-03-16
10840277411799HS FiberHS2442026-03-16
00840277411808HS FiberHS2452026-03-16
10840277411812Gold MarkerGM0453-20202026-03-11
00812444029673OrthoButton ALOBAL802026-03-03
00840277411068HS FiberDFX00182026-01-26
00840277411396HS FiberHS9032026-01-13
10840277411409HS FiberHS9042026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747457Polyglactin 910HEALTHIUM MEDTECH LIMITEDGAM2026-05-25
00810126508331Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508348Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
10817169023019Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00817169023005Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508232Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508249Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508256Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508263Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
03661522100189OPTIME®PETERS SURGICALGAM2026-03-09
03661522100196OPTIME®PETERS SURGICALGAM2026-03-09
03661522100219OPTIME®PETERS SURGICALGAM2026-03-09
03661522100714OPTIME®PETERS SURGICALGAM2026-03-09
03661522100721OPTIME®PETERS SURGICALGAM2026-03-09
03661522100738OPTIME®PETERS SURGICALGAM2026-03-09
03661522100752OPTIME®PETERS SURGICALGAM2026-03-09
03661522100868OPTIME®PETERS SURGICALGAM2026-03-09
03661522100875OPTIME®PETERS SURGICALGAM2026-03-09
03661522101414OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101421OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101438OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101445OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101452OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101469OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101476OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101483OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101490OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101506OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101513OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101575OPTIME®PETERS SURGICALGAM2026-03-09