FDA.report

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Primary DI
07540194007117
Brand
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Company
Pega Medical Inc
Model
MDR164
Catalog number
MDR164
Device description
MALE DRIVER Ø6.4mm
Published
2020-05-06
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
false

Related Records

Contact Domains

Product Codes

CodeName
HXXSCREWDRIVER
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540194007117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540194007117075401940071177540194007117

GMDN Terms

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

TypeValueUnit
Outer Diameter6.4Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(450)688-5144egarcia@pegamedical.com

Regulatory Flags

DUNS number
257315713
Device count
1
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 DIBrandModelCatalogPublished
07540194017949GIRO GROWTH MODULATION SYSTEMGRO-CYE200-35GRO-CYE200-352025-03-31
07540194017956GIRO GROWTH MODULATION SYSTEMGRO-CYF250-35GRO-CYF250-352025-03-31
07540194009678FREE GLIDING SCFE SCREW SYSTEMSCF-CSIN525SCF-CSIN5252024-09-11
07540194012050SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-20PEG-CFL-202024-09-11
07540194012067SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-24PEG-CFL-242024-09-11
07540194012074SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-28PEG-CFL-282024-09-11
07540194014238FASSIER-DUVAL TELESCOPIC IM SYSTEMFC-CUT100FC-CUT1002024-09-11
07540194015853HINGE PEDIATRIC PLATING SYSTEMHP-CSF250HP-CSF2502024-09-11
07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11
07540194015945GIRO GROWTH MODULATION SYSTEMGRO-CYF150-60GRO-CYF150-602024-09-11
07540194015976Dr.Paleys Osteotomy SystemDRPBC-201DRPBC-2012024-09-11
07540194015990FASSIER-DUVAL TELESCOPIC IM SYSTEMFC-KNB100FC-KNB1002024-09-11
07540194016034Dr.Paleys Osteotomy SystemDRPFO-201DRPFO-2012024-09-11
07540194016041Dr.Paleys Osteotomy SystemDRPCP-201DRPCP-2012024-09-11
07540194016607GAP ENDO-EXO MEDULLARY SYSTEMGAP-TMP200GAP-TMP2002024-09-11
07540194016799GAP ENDO-EXO MEDULLARY SYSTEMGAP-RSC200GAP-RSC2002024-09-11
07540194016836GAP ENDO-EXO MEDULLARY SYSTEMGAP-IME200GAP-IME2002024-09-11
07540194016843GAP ENDO-EXO MEDULLARY SYSTEMGAP-IMF200GAP-IMF2002024-09-11
07540194016867GAP ENDO-EXO MEDULLARY SYSTEMGAP-IME250GAP-IME2502024-09-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19