FDA.reportPublic FDA data

WEGO-PGLA RAPID Absorbable Surgical Suture With Needle

Primary DI
06941813699811
Brand
WEGO-PGLA RAPID Absorbable Surgical Suture With Needle
Company
Foosin Medical Supplies Inc., Ltd.
Model
J43130-45
Published
2020-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183001000WEGO-PGLA RAPIDFoosin Medical Supplies Inc., Ltd.2019-01-28GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941813699811PackageGS112In Commercial Distribution
06941813609810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941813699811069418136998116941813699811
06941813609810069418136098106941813609810

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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
528180159
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052493SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
00848782052509SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
17891338994365VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994389VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994396VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994440VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994457VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994501VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994532VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994556VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994563VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994570VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994839VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994860VICRYL RAPIDEETHICON, LLCGAM2026-07-03
00840277412065ViletRIVERPOINT MEDICAL, LLCGAM2026-06-08
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