FDA.report

GAP ENDO-EXO MEDULLARY SYSTEM

Primary DI
07540194010155
Brand
GAP ENDO-EXO MEDULLARY SYSTEM
Company
Pega Medical Inc
Model
GAP-PLB110
Catalog number
GAP-PLB110
Device description
GAP PLATE BENDER "F"
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
HXWBENDER

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540194010155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540194010155075401940101557540194010155

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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
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
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07540194012074SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-28PEG-CFL-282024-09-11
07540194014238FASSIER-DUVAL TELESCOPIC IM SYSTEMFC-CUT100FC-CUT1002024-09-11
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07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11
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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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