FDA.reportPublic FDA data

NeuroPro®

Primary DI
00898142001005
Brand
NeuroPro®
Company
Kinamed, Inc.
Model
14-1P1-0211
Catalog number
14-1P1-0211
Device description
Bone Plate
Published
2015-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898142001005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898142001005008981420010058981420010050898142001005

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818720013305SuperCable® ISO-Elastic™ Cerclage System35-880-206035-880-20602022-10-03
00818720013312SuperCable® ISO-Elastic™ Cerclage System35-880-106035-880-10602022-10-03
00818720013329SuperCable® ISO-Elastic™ Cerclage System35-880-104035-880-10402022-10-03
00818720013336SuperCable® ISO-Elastic™ Cerclage System35-880-204035-880-20402022-10-03
00818720013299SuperCable® ISO-Elastic™ Cerclage System35-880-306035-880-30602022-09-27
00818720013381SuperCable® ISO-Elastic™ Cerclage System35-800-302235-800-30222026-05-29
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
00898142001906NeuroPro®14-1P1-127714-1P1-12772023-05-15
00898142001029NeuroPro®14-1P1-081014-1P1-08102015-11-05
00898142001036NeuroPro®14-1P1-081214-1P1-08122015-11-05
00898142001050NeuroPro®14-1P1-041314-1P1-04132015-11-05
00898142001067NeuroPro®14-1P2-011414-1P2-01142015-11-05

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