FDA.report

PRECICE® Intramedullary Limb Lengthening System

Primary DI
00812258025199
Brand
PRECICE® Intramedullary Limb Lengthening System
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
PR9.0-50C195
Catalog number
PR9.0-50C195
Device description
Orthopedic intramedullary limb lengthening rod, antegrade tibia, 9.0 mm diameter, 195 mm length
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

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
00812258025199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258025199008122580251998122580251990812258025199

GMDN Terms

TermDefinition
Tibia nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, 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, or for knee arthrodesis. 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
Outer Diameter9Millimeter

Sterilization Methods

Method

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
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

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00195377066305Precice Ankle Salvage SystemAST1-0002023-01-26
00195377066701Precice InstrumentSPT1-0002023-01-26
00195377066718Precice InstrumentSPR1-0002023-01-26
00812258028602Precice InstrumentSDG2-0002023-01-26
00887517001238Precice InstrumentOSG1-0002023-01-26
00887517001252Precice InstrumentOSG3-0002023-01-26
00887517001290Precice InstrumentCRT1-0002023-01-26
00887517001313Precice InstrumentOSP5-0752023-01-26
00887517001320Precice InstrumentOSP5-1002023-01-26
00887517054272Precice InstrumentsOTA1-0002023-01-26
00887517885234Precice InstrumentHCB3-0002023-01-26
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
00195377168603PRECICE ScrewsTSA5-070TSA5-0702017-10-09
00195377168610PRECICE ScrewsTSA5-060TSA5-0602017-10-09

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