FDA.report

NeuroPro®

Primary DI
00818720010489
Brand
NeuroPro®
Company
Kinamed, Inc.
Model
14-1DM-1605
Catalog number
14-1DM-1605
Device description
Drill for 1.6mm screw, 5mm depth, Midas Rex
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818720010489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818720010489008187200104898187200104890818720010489

GMDN Terms

TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
184896645
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00898142001975SuperCable® Iso-Elastic™ Cerclage System37-100-101037-100-10102015-11-04
00898142001302NeuroPro®14-1S3-160514-1S3-16052015-11-09
00898142001319NeuroPro®14-1S3-160414-1S3-16042015-11-09
00898142001760NeuroPro® Low Profile16-1S3-163516-1S3-16352015-11-06
00898142001777NeuroPro® Low Profile16-1S3-160416-1S3-16042015-11-06
00898142001784NeuroPro® Low Profile16-1S3-160516-1S3-16052015-11-06
10898142001347CarboJet® CO2 Bone Lavage System25-100-200125-100-20012016-05-18
00898142001470CarboJet® CO2 Bone Lavage System25-200-020025-200-02002016-05-17
00898142001487CarboJet® CO2 Bone Lavage System25-200-022025-200-02202016-05-18
00898142001494CarboJet® CO2 Bone Lavage System25-200-023025-200-02302016-05-18
00898142001500CarboJet® CO2 Bone Lavage System25-200-024225-200-02422016-05-18
00898142001517CarboJet® CO2 Bone Lavage System25-200-024425-200-02442016-05-18
00898142001524CarboJet® CO2 Bone Lavage System25-200-024625-200-02462016-05-18
00818720010724NeuroPro®14-1T2-010014-1T2-01002023-07-10
00818720011288KineMatch® PFR SystemCustom 260Custom 2602023-07-10
00818720011295KineMatch® PFR SystemCustom 261Custom 2612023-07-10
00818720012414CarboJet XF® Bone Preparation System27-100-100027-100-10002023-07-10
00818720012421CarboJet XF® Bone Preparation System27-100-101027-100-10102023-07-10

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