FDA.report

PRECICE® Trauma Intramedullary Nail System Instrument

Primary DI
00812258028107
Brand
PRECICE® Trauma Intramedullary Nail System Instrument
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
HTA1-000
Catalog number
HTA1-000
Device description
Orthopedic surgical instrument (targeting arm) - for use with the trauma intramedullary rod, humerus
Published
2016-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812258028107PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00812258028107140081225802810708122580281070812258028107Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Humerus nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the humerus, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
855-435-5477csdepartment@ellipse-tech.com
866-456-2871info@globusmedical.com

Regulatory Flags

DUNS number
837845234
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
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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00887517054272Precice InstrumentsOTA1-0002023-01-26
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00887517937148Precice InstrumentKWS1-0022023-01-26
00887517937155Precice InstrumentKWS2-0002023-01-26
00195377168276PRECICE ScrewsTSA5-100TSA5-1002017-10-09
00195377168283PRECICE ScrewsTSA5-095TSA5-0952017-10-09
00195377168290PRECICE ScrewsTSA5-080TSA5-0802017-10-09
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