FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118605779
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
EG41133-60
Catalog number
EG41133-60
Device description
Endure PGA Sutures, Violet 13 mm, 3/8 Taper, 60 cm, 4-0
Published
2023-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K073614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073614000WG-SURGICAL SUTURES WITH NEEDLEFoosin Medical Supplies, Inc.2008-04-30NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118605779PackageGS112In Commercial Distribution
00840118605786PackageGS11200In Commercial Distribution
00840118605762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118605779008401186057798401186057790840118605779
00840118605786008401186057868401186057860840118605786
00840118605762008401186057628401186057620840118605762

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 607-299-4971support@endureind.com

Regulatory Flags#

DUNS number
066087031
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
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
00840118617567Endure IndustriesECLJBSECLJBS-302026-08-03
00840118617581Endure IndustriesECLJBMECLJBM2026-08-03
00840118617604Endure IndustriesECLJBLECLJBL2026-08-03
00840118617628Endure IndustriesECLJBXLECLJBXL2026-08-03
00840118617659ENDURE INDUSTRIESELCKSELCKS2026-08-03
00840118617673Endure IndustriesELCKMELCKM2026-08-03
00840118617697Endure IndustriesELCKLELCKL2026-08-03
00840118617710Endure IndustriesELCKXLELCKXL2026-08-03
00840118617741Endure IndustriesELCKXXLELCKXXL2026-08-03
00840118617772Endure IndustriesELCTSELCTS2026-08-03
00840118617802Endure IndustriesELCTMELCTM2026-08-03
00840118620444ENDURE INDUSTRIESGSTMGSTM2026-08-03
00840118620468ENDURE INDUSTRIESGSTLGSTL2026-08-03
00840118620482ENDURE INDUSTRIESGSTXGSTX2026-08-03
00840118687690Endure IndustriesELCTLELCTL2026-08-03
00840118698399Endure IndustriesELCTXLELCTXL2026-08-03
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046963535797NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535810NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535995NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536176NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536213NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535438NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535537NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535636NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535674NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534578NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534752NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534776NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534998NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535278NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535315NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535339NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535391NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535575NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535698NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535971NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536015NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536138NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536190NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536251NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536275NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536312NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536350NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536596NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536695NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536770NovosynB BRAUN SURGICAL SAGAM2015-08-12