FDA.reportPublic FDA data

Oasis

Primary DI
B031MVY9430
Brand
Oasis
Company
American Health Service Sales Corporation
Model
MV-Y943
Device description
SUTURE, MONOFYL, 2-0, NFS-1
Published
2016-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130737000SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.2014-01-14GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B031MVY9431PackageHIBCC12In Commercial Distribution
B031MVY9432PackageHIBCC100In Commercial Distribution
B031MVY9430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Poliglecaprone sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
556115970
Device count
1
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
B031AH01T25160AHSAH01T25162016-03-31
B031AH01T27130AHSAH01T27132016-03-31
B031AH03L18250AHSAH03L18252016-03-31
B031AH03L18380AHSAH03L18382016-03-31
B031AH03L20250AHSAH03L20252016-03-31
B031AH03L20380AHSAH03L20382016-03-31
B031AH03L21250AHSAH03L21252016-03-31
B031AH03L22190AHSAH03L22192016-03-31
B031AH03L22250AHSAH03L22252016-03-31
B031AH03L22380AHSAH03L22382016-03-31
B031AH03L23250AHSAH03L23252016-03-31
B031AH03L25160AHSAH03L25162016-03-31
B031AH03L25250AHSAH03L25252016-03-31
B031AH03L25380AHSAH03L25382016-03-31
B031AH03L27380AHSAH03L27382016-03-31
B031AH03S22190AHSAH03S22192016-03-31
B031AH05M29130AHSAH05M29132016-03-31
B031AH05M2913400AHSAH05M2913402016-03-31
B031AH10M29130AHSAH10M29132016-03-31
B031AH10M2913400AHSAH10M2913402016-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224453MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
10705031464285STRATAFIXETHICON, LLCGAM2023-03-24
10705031464292STRATAFIXETHICON, LLCGAM2023-03-24
10705031464308STRATAFIXETHICON, LLCGAM2023-03-24
10705031464315STRATAFIXETHICON, LLCGAM2023-03-24
10705031464322STRATAFIXETHICON, LLCGAM2023-03-24
10705031464339STRATAFIXETHICON, LLCGAM2023-03-24
10705031464346STRATAFIXETHICON, LLCGAM2023-03-24
10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24