FDA.reportPublic FDA data

WEGO-PGLA Absorbable Surgical Suture With Needle

Primary DI
06941813620020
Brand
WEGO-PGLA Absorbable Surgical Suture With Needle
Company
Foosin Medical Supplies Inc., Ltd.
Model
A1004506
Published
2016-04-13
Public version status
Update
Distribution status
Not 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
K130735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130735000SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.2014-01-14GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941813625025PackageGS112In Commercial Distribution
06941813620020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941813625025069418136250256941813625025
06941813620020069418136200206941813620020

GMDN Terms#

Term, Definition table
TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. 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
528180159
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941813660019WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE1006004B2016-04-10
06941813660026WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE10060122016-04-18
06941813660033WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE1007505R2016-04-18
06941813660040WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE1025001R2016-04-18
06941813660057WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE112622016-04-18
06941813660064WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE11262DB2016-04-18
06941813660071WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE11262D2016-04-18
06941813660088WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE113022016-04-18
06941813660095WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE11302B2016-04-18
06941813660101WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE114022016-04-18
06941813660118WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE133032016-04-18
06941813660125WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE134032016-04-18
06941813660132WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE135002016-04-18
06941813660149WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE136502016-04-18
06941813660156WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE174822016-04-18
06941813660163WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE20060012016-04-18
06941813660170WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE2006004B2016-04-18
06941813660187WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE20060122016-04-18
06941813660194WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE20150012016-04-18
06941813660200WEGO-Polyester Nonabsorbable Surgical Suture With NeedleE20250012016-04-18

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Primary DI, Brand, Company table
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