FDA.reportPublic FDA data

NeuroPro®

Primary DI
10898142001330
Brand
NeuroPro®
Company
Kinamed, Inc.
Model
14-1S4-1605
Catalog number
14-1S4-1605
Device description
Bone Screw, Quick Tap® Self-Drilling, 1.6x5mm (10pcs/pkg)
Published
2015-12-31
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
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898142001330PrimaryGS10
00898142001333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089814200133010898142001330
00898142001333008981420013338981420013330898142001333

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate screwA small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
10
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
00898142001005NeuroPro®14-1P1-021114-1P1-02112015-11-09
00898142001029NeuroPro®14-1P1-081014-1P1-08102015-11-05
00898142001036NeuroPro®14-1P1-081214-1P1-08122015-11-05
00898142001050NeuroPro®14-1P1-041314-1P1-04132015-11-05

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Primary DI, Brand, Company table
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ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
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