FDA.report

HPS Trocar

Primary DI
04260148896231
Brand
HPS Trocar
Company
Paradigm Spine, LLC
Model
HAT50100
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260148896231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260148896231042601488962314260148896231

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
787874960
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
false
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

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04260148898235CoFix Implant 8 mmRQI00008RQI000082020-03-19
04260148898242CoFix Implant 10 mmRQI00010RQI000102020-03-19
04260148898259CoFix Implant 12 mmRQI00012RQI000122020-03-19
04260148898266CoFix Implant 14 mmRQI00014RQI000142020-03-19
04260148898273CoFix Implant 16 mmRQI00016RQI000162020-03-19
04260148897931CoFix Sterilization TrayRAC100002020-03-04
04260636670459coflex-F LIS screw inserterRAT202222020-03-04
04260148896927DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI850452015-10-01
04260148897825coflex crimping pliers, longUAT102502018-10-23
04260148897849coflex dual pliersUAT102602018-10-10
04260148894282DSS Pedicle Screw Set, Ø5.0 x 60mmDPI550602018-08-03
04260148894299DSS Pedicle Screw Set, Ø6.0 x 60mmDPI560602018-08-03
04260148894305DSS Pedicle Screw Set, Ø7.0 x 60mmDPI570602018-08-03
04260148897856coflex MalletUAT201202018-08-02
04260148897863coflex mallet capUAT201302018-08-02
04260148897740coflex trial with guide and x-ray marker, 8mmUXT100082018-06-28
04260148897757coflex trial with guide and x-ray marker, 10mmUXT100102018-06-28
04260148897764coflex trial with guide and x-ray marker, 12mmUXT100122018-06-28
04260148897771coflex trial with guide and x-ray marker, 14mmUXT100142018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmUXT100162018-06-28

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