FDA.reportPublic FDA data

MONOSWIFT

Primary DI
10790986001593
Brand
MONOSWIFT
Company
C.P. MEDICAL CORPORATION
Model
L1026
Catalog number
L1026
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K072229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072229000MONOSWIFTCp Medical2007-10-05GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20790986001590PackageGS112In Commercial Distribution
10790986001593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2079098600159020790986001590
1079098600159310790986001593

GMDN Terms#

Term, Definition table
TermDefinition
Polyglyconate sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended 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
Ethylene Oxide

Regulatory Flags#

DUNS number
807404611
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10790986006291FN NEEDLESFN18-51TFN18-51T2016-02-19
10790986006307FN NEEDLESFN18-3TFN18-3T2016-02-19
10790986006314FN NEEDLESFN18-1TFN18-1T2016-02-19
10790986006321FN NEEDLESFN17-51TFN17-51T2016-02-19
10790986006338FN NEEDLESFN17-3TFN17-3T2016-02-19
10790986006345FN NEEDLESFN17-1TFN17-1T2016-02-19
10790986007038FN NEEDLESFN18-53T2017-11-06
10790986004181POLYBONDCP24A2015-09-24
10790986004198POLYBONDCP25A2015-09-24
10790986004204POLYBONDCP34A2015-09-24
10790986004211POLYBONDCP35A2015-09-24
10790986004228POLYBONDCP43ACP43A2015-12-21
10790986004235POLYBONDCP52ACP52A2015-12-21
10790986004242POLYBONDCP54ACP54A2015-12-21
10790986004259POLYBONDCP58SA2015-09-24
10790986004266POLYBONDCP77ACP77A2015-12-21
10790986004273POLYBONDCP88A2015-09-24
10790986004280POLYBONDCP513A2015-09-24
10790986004297POLYBONDCP23A2015-09-24
10790986004303POLYBONDCP553A2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521839830TrexonCovidien LPGAM2026-10-10
10884521839861TrexonCovidien LPGAM2026-10-10
10884521840089TrexonCovidien LPGAM2026-10-10
10884521840126TrexonCovidien LPGAM2026-10-10
10884521840140TrexonCovidien LPGAM2026-10-10
10884521840171TrexonCovidien LPGAM2026-10-10
10884521840195TrexonCovidien LPGAM2026-10-10
10884521840249TrexonCovidien LPGAM2026-10-10
10884521840263TrexonCovidien LPGAM2026-10-10
10884521840270TrexonCovidien LPGAM2026-10-10
10884521840379TrexonCovidien LPGAM2026-10-10
10884521840409TrexonCovidien LPGAM2026-10-10
10884521840430TrexonCovidien LPGAM2026-10-10
10884521840447TrexonCovidien LPGAM2026-10-10
10884521840454TrexonCovidien LPGAM2026-10-10
10884521840461TrexonCovidien LPGAM2026-10-10
10884521840478TrexonCovidien LPGAM2026-10-10
10884521840485TrexonCovidien LPGAM2026-10-10
10884521840492TrexonCovidien LPGAM2026-10-10
10884521840508TrexonCovidien LPGAM2026-10-10
10884521840591TrexonCovidien LPGAM2026-10-10
10884521840614TrexonCovidien LPGAM2026-10-10
10884521840645TrexonCovidien LPGAM2026-10-10
10884521840652TrexonCovidien LPGAM2026-10-10
10884521840669TrexonCovidien LPGAM2026-10-10
10884521840676TrexonCovidien LPGAM2026-10-10
10884521840683TrexonCovidien LPGAM2026-10-10
10884521840690TrexonCovidien LPGAM2026-10-10
10884521840706TrexonCovidien LPGAM2026-10-10
10884521840720TrexonCovidien LPGAM2026-10-10