FDA.report

GAP ENDO-EXO MEDULLARY SYSTEM

Primary DI
07540194010391
Brand
GAP ENDO-EXO MEDULLARY SYSTEM
Company
Pega Medical Inc
Model
GAP-ILFRENT
Catalog number
GAP-ILFRENT
Device description
GAP LAG INSTRUMENTS CASE RENTAL
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
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540194010391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540194010391075401940103917540194010391

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

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
true
Combination product
false
Lot or batch
false
Serial number
true
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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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
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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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