FDA.report

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Primary DI
07540194007544
Brand
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Company
Pega Medical Inc
Model
MR232-S
Catalog number
MR232-S
Device description
COIL-PULLER SHAFT Ø3.2mm
Published
2020-05-07
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

Related Records

Contact Domains

Product Codes

CodeName
HWBEXTRACTOR
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540194007544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540194007544075401940075447540194007544

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
Lumen/Inner Diameter2.1Millimeter

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
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

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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

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