FDA.reportPublic FDA data

FREE GLIDING SCFE SCREW SYSTEM

Primary DI
07540194010803
Brand
FREE GLIDING SCFE SCREW SYSTEM
Company
Pega Medical Inc
Model
SCF-GWR328-PKG6
Catalog number
SCF-GWR328-PKG6
Device description
SCFE GUIDE WIRE Ø2.80mm - PACKAGE OF 6
Published
2020-08-12
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
07540194008190PrimaryGS10
07540194010803Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194008190075401940081907540194008190
07540194010803075401940108037540194010803

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length330Millimeter
Outer Diameter2.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
257315713
Device count
6
DM exempt
false
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
07540194015952HINGE PEDIATRIC PLATING SYSTEMHP-GWR250-PKG2HP-GWR250-PKG22023-11-16
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
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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00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
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00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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