FDA.reportPublic FDA data

VIOLA

Primary DI
08800256050727
Brand
VIOLA
Company
MEDITIME CO., LTD.
Model
DVMXS29060C-60090X
Catalog number
DVMXS29060C-60090X
Published
2024-06-04
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
NEWSuture, Surgical, Absorbable, Polydioxanone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190264000ViolaMeditime Co., Ltd.2019-08-15NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800256050727PackageGS15In Commercial Distribution
08800256050710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800256050727088002560507278800256050727
08800256050710088002560507108800256050710

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
689774482
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
false
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
08800256051397VIOLA19G 100mm, USP : 0/200mmDVAGR19100L-00200X2026-04-07
08800256051090LES ENCRESDVSRR21100L-30150XDVSRR21100L-30150X2024-06-19
08800256050000VIOLA110mm, USP : 2-0/290mm2024-05-02
08800256050024VIOLA110mm, USP : 2-0/440mm2024-05-02
08800256050185VIOLA19G 38mm, USP : 0/40mm2024-05-02
08800256050239VIOLADVAGR19100L-00170XDVAGR19100L-00170X2024-05-02
08800256050277VIOLA19G 100mm, USP : 0/165mm2024-05-02
08800256050291VIOLA20G 100mm, USP : 2-0/165mm2024-05-02
08800256050314VIOLA20G 70mm, USP : 2-0 / 135mm2024-05-02
08800256050338VIOLA110mm, USP : 2/320mm2024-06-03
08800256050352VIOLA130mm, USP : 2/480mm2024-06-03
08800256050376VIOLA110mm, USP : 2/480mm2024-06-03
08800256050390VIOLA130mm, USP : 2/390mm2024-06-03
08800256050413VIOLA130mm, USP : 2/570mm2024-06-03
08800256050437VIOLADVMXR27038C-50050XDVMXR27038C-50050X2024-06-03
08800256050451VIOLADVMXR27060C-50090XDVMXR27060C-50090X2024-06-03
08800256050475VIOLADVMXR29025C-60030XDVMXR29025C-60030X2024-06-03
08800256050499VIOLADVMXR29038C-60050XDVMXR29038C-60050X2024-06-03
08800256050512VIOLADVMXR30025C-60030XDVMXR30025C-60030X2024-06-03
08800256050536VIOLADVMXR30025B-60030XDVMXR30025B-60030X2024-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255243903PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244009PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244016PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247628PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247697PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250925PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251021PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251168PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252141PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252158PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252301PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252318PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252332PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252349PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252370PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252820PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255253049PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256422PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256637PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256743PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257252PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257269PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257276PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255234277PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234284PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234291PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234307PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234314PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234321PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04