FDA.reportPublic FDA data

HINGE PEDIATRIC PLATING SYSTEM

Primary DI
07540194015952
Brand
HINGE PEDIATRIC PLATING SYSTEM
Company
Pega Medical Inc
Model
HP-GWR250-PKG2
Catalog number
HP-GWR250-PKG2
Device description
HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 - PACK OF 2
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194015822PrimaryGS10
07540194015952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194015822075401940158227540194015822
07540194015952075401940159527540194015952

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.1Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(450)688-5144egarcia@orthopediatrics.ca

Regulatory Flags#

DUNS number
257315713
Device count
2
DM exempt
true
Premarket exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540194010735HINGE PEDIATRIC PLATING SYSTEMHPW150-PKG2HPW150-PKG22023-11-16
07540194010742HINGE PEDIATRIC PLATING SYSTEMHPW150-PKG6HPW150-PKG62023-11-16
07540194012739SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMBLT-GWR100-PKG6BLT-GWR100-PKG62023-11-16
07540194012746SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMBLT-GWR200-PKG6BLT-GWR200-PKG62023-11-16
07540194015969HINGE PEDIATRIC PLATING SYSTEMHP-GWR250-PKG6HP-GWR250-PKG62023-11-16
07540194014993FASSIER-DUVAL TELESCOPIC IM SYSTEMG-WIRE 018-PKG2G-WIRE 018-PKG22022-04-30
07540194015006FASSIER-DUVAL TELESCOPIC IM SYSTEMG-WIRE 018-PKG6G-WIRE 018-PKG62022-04-30
07540194014931SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-GWR180-PKG 6SLM-GWR180-PKG 62022-03-02
07540194010872SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-GWR160-PKG 6SLM-GWR160-PKG 62020-08-13
07540194010889SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-GWR200-PKG 6SLM-GWR200-PKG 62020-08-13
07540194010759FREE GLIDING SCFE SCREW SYSTEMSCF-GWR320-PKG2SCF-GWR320-PKG22020-08-12
07540194010766FREE GLIDING SCFE SCREW SYSTEMSCF-GWR320-PKG6SCF-GWR320-PKG62020-08-12
07540194010773FREE GLIDING SCFE SCREW SYSTEMSCF-GWR324-PKG2SCF-GWR324-PKG22020-08-12
07540194010780FREE GLIDING SCFE SCREW SYSTEMSCF-GWR324-PKG6SCF-GWR324-PKG62020-08-12
07540194010797FREE GLIDING SCFE SCREW SYSTEMSCF-GWR328-PKG2SCF-GWR328-PKG22020-08-12
07540194010803FREE GLIDING SCFE SCREW SYSTEMSCF-GWR328-PKG6SCF-GWR328-PKG62020-08-12
07540194010810FREE GLIDING SCFE SCREW SYSTEMSCF-GWR320-CoCr-PKG2SCF-GWR320-CoCr-PKG22020-08-12
07540194010827FREE GLIDING SCFE SCREW SYSTEMSCF-GWR320-CoCr-PKG6SCF-GWR320-CoCr-PKG62020-08-12
07540194010834FREE GLIDING SCFE SCREW SYSTEMSCF-GWR324-CoCr-PKG2SCF-GWR324-CoCr-PKG22020-08-12
07540194010841FREE GLIDING SCFE SCREW SYSTEMSCF-GWR324-CoCr-PKG6SCF-GWR324-CoCr-PKG62020-08-12

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Primary DI, Brand, Company table
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00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
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20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03