FDA.reportPublic FDA data

Mono Q®

Primary DI
10810020088851
Brand
Mono Q®
Company
RIVERPOINT MEDICAL, LLC
Model
Q1525
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
10810020088851PackageGS112In Commercial Distribution
00810020088854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008885110810020088851
00810020088854008100200888548100200888540810020088854

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
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
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
08904255257412PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257443PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257450PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257467PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257474PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257481PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255234369PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234376PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234390PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234406PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257306PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257313PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257320PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257337PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257344PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257351PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257368PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257375PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257382PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257399PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257405PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257429PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257436PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08903837198907MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837198921MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837149251MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149275MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149237MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-08-31
08809766324533V-Loc 90 DeltaSamyang Holdings CorporationGAM2023-05-31