FDA.reportPublic FDA data

PRECICE® Intramedullary Limb Lengthening System Instrument

Primary DI
00812258021801
Brand
PRECICE® Intramedullary Limb Lengthening System Instrument
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
CRA1-000
Catalog number
CRA1-000
Device description
Orthopedic surgical instrument - for use with the intramedullary limb lengthening system
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812258021801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258021801008122580218018122580218010812258021801

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195377024282Precice InstrumentOSR2-0002023-01-26
00195377066206Precice InstrumentSPAS-3.22023-01-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868150876Affixus®Zimmer, Inc.HSB2026-03-20
00887868150333Affixus®Zimmer, Inc.HSB2026-03-19
00887868150340Affixus®Zimmer, Inc.HSB2026-03-19
00887868150357Affixus®Zimmer, Inc.HSB2026-03-19
00887868150364Affixus®Zimmer, Inc.HSB2026-03-19
00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
00887868150586Affixus®Zimmer, Inc.HSB2026-03-19
00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16