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
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31
00840118603850EndureSLL50A3-0520SLL50A32020-08-31
00840118603881EndureSLS1A3-0520SLS1A32020-09-15
00840118603911EndureSLS2A3-0520SLS2A32020-09-15
00840118603942EndureSLS3A3-0520SLS3A32020-09-15
00840118603973EndureSLS5A3-0520SLS5A32020-09-15

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
10705031472143Coated VICRYLETHICON, LLCGAM2026-05-08
10705031472174MONOCRYLETHICON, LLCGAM2026-05-08
10705031472181MONOCRYLETHICON, LLCGAM2026-05-08
10705031472198MONOCRYLETHICON, LLCGAM2026-05-08
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