FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118611336
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
E11H90CX16
Catalog number
E11H90CX16
Device description
Endure Sutures PGCL Undyed, 16mm, 3/8 PRC, 90cm, 5-0
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K130737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130737000SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.2014-01-14GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118611336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118611336008401186113368401186113360840118611336

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
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
00840118621137Endure IndustriesOMEP11OMEP112026-08-17
00840118600361Endure IndustriesNDAFC211NDAFC2112026-08-14
00840118602150Endure IndustriesECAKCDQ-118ECAKCDQ-1182026-08-14
00840118607988Endure IndustriesNCAC211NCAC2112026-08-14
00840118609616Endure IndustriesNDAMC211NDAMC2112026-08-14
00840118614245Endure IndustriesESP38ESP382026-08-14
00840118614252Endure IndustriesESP310ESP3102026-08-14
00840118614269Endure IndustriesESP511ESP5112026-08-14
00840118614276Endure IndustriesESP516ESP5162026-08-14
00840118614283Endure IndustriesESP713ESP7132026-08-14
00840118614290Endure IndustriesESP916ESP9162026-08-14
00840118614306Endure IndustriesESP1118ESP11182026-08-14
00840118614900Endure IndustriesNDAF211NDAF2112026-08-14
00840118616447Endure IndustriesEBSEBS2026-08-14
00840118617338Endure IndustriesNDAM411UNDAM411U2026-08-14
00840118617352Endure IndustriesNDAM411NDAM4112026-08-14
00840118617376Endure IndustriesNDAF411UNDAF411U2026-08-14
00840118617390Endure IndustriesNDAF411NDAF4112026-08-14
00840118617413Endure IndustriesNCPC211NCPC2112026-08-14
00840118617437Endure IndustriesNDPM211NDPM2112026-08-14

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Primary DI, Brand, Company table
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10705031464438STRATAFIXETHICON, LLCGAM2023-03-24