FDA.reportPublic FDA data

ORTHOCORD

Primary DI
20886705022943
Brand
ORTHOCORD
Company
Medos International Sàrl
Model
223127
Catalog number
223127
Device description
ORTHOCORD Violet Braided Composite Suture C-1 13 mm 3/8c, Taper Point N=1 Meets U.S.P. and E.P. except for diameter 4-0 (1.5 metric), 18 Inches (45 cm)
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123668000ORTHOCORDDepuy Mitek, Inc., A Johnson and Johnson Company2013-02-26NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705022943PackageGS112In Commercial Distribution
10886705022946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670502294320886705022943
1088670502294610886705022946

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963474109MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474116MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474123MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478428MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478435MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478459MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
18800145524299Miracu FCL LSCO 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525913JBP V Line Edge 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525920JBP V Line Force 19Gx70mmFeeltech Co.,Ltd.NEW2026-08-25
08809963477384MINTHans Biomed Corp.NEW2026-07-28
08809963477445MINTHans Biomed Corp.NEW2026-07-28
08809963477858MINTHans Biomed Corp.NEW2026-07-28
08904255243903PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244009PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
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08904255247628PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247697PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250925PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251021PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251168PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252141PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252158PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252301PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252318PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252332PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252349PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252370PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252820PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255253049PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05