FDA.reportPublic FDA data

SuperCable® Iso-Elastic™ Cerclage System

Primary DI
00898142001357
Brand
SuperCable® Iso-Elastic™ Cerclage System
Company
Kinamed, Inc.
Model
35-100-1010
Catalog number
35-100-1010
Device description
1.5mm Polymer Cable with Ti Clasp
Published
2015-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898142001354PackageGS13Not in Commercial Distribution
20898142001351PackageGS16Not in Commercial Distribution
00898142001357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089814200135410898142001354
2089814200135120898142001351
00898142001357008981420013578981420013570898142001357

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone cerclage cableAn implantable braided metallic cord intended to be tightened with a crimp-like component to form a loop or ring around a fractured bone and/or fixation plate as part of an orthopaedic treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.

Regulatory Flags#

DUNS number
184896645
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
00818720011608SuperCable® Grip and Plate System35-860-206535-860-20652023-06-21
00818720011547SuperCable® Grip and Plate System35-860-102035-860-10202023-06-20
00818720011578SuperCable® Grip and Plate System35-860-202035-860-20202023-06-20
00818720011585SuperCable® Grip and Plate System35-860-203035-860-20302023-06-20
00898142001975SuperCable® Iso-Elastic™ Cerclage System37-100-101037-100-10102015-11-04
00818720012438CarboJet XF® Bone Preparation System27-100-114027-100-11402023-07-10
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00818720010113SuperCable® Grip and Plate System35-230-451035-230-45102015-10-30
00818720010120SuperCable® Grip and Plate System35-230-451235-230-45122015-10-30
00818720010137SuperCable® Grip and Plate System35-230-451435-230-45142015-10-30
00818720010144SuperCable® Grip and Plate System35-230-451635-230-45162015-10-30
00818720010151SuperCable® Grip and Plate System35-230-451835-230-45182015-10-30

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