PASS MED

GUDID 03613720206637

RIGHT SACRAL PLATE

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID03613720206637
NIH Device Record Keya2085f7e-3e17-4fe9-aef9-878d92bf552b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS MED
Version Model NumberMS030
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720206637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

[03613720206637]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-05-23
Device Publish Date2015-10-23

On-Brand Devices [PASS MED]

03613720209744LAMINAR THORACIC HOOK FOR SHORT CLAW 7mm - Small
03613720206613PARALLEL CLOSED DOMINO
03613720206590PARALLEL OPEN/CLOSED DOMINO
03613720235040SACRAL SCREW Ø 7.2mm x 50mm
03613720235033SACRAL SCREW Ø 7.2mm x 46mm
03613720235026SACRAL SCREW Ø 7.2mm x 42mm
03613720235019SACRAL SCREW Ø 7.2mm x 38mm
03613720235002SACRAL SCREW Ø 7.2mm x 34mm
03613720234999SACRAL SCREW Ø 6.5mm x 60mm
03613720234982SACRAL SCREW Ø 6.5mm x 55mm
03613720234975SACRAL SCREW Ø 6.5mm x 50mm
03613720234968SACRAL SCREW Ø 6.5mm x 45mm
03613720234951POLYAXIAL PEDICULAR CYLINDRICAL SCREW OFFSET 3mm 5,5 x 38
03613720225997ROD FOR IN SITU BENDING Ø 6mm x 500mm
0361372022598048 TO 62 mm PLATE FOR CROSSLINK 48 to 62mm
0361372022597334 TO 48 mm PLATE FOR CROSSLINK 34 to 48mm
0361372022596622 TO 34 mm PLATE FOR CROSSLINK 22 to 34mm
03613720225959CROSSLINK CONNECTOR
03613720210238POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 54
03613720210221POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 50
03613720210214POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 46
03613720210207POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 42
03613720210191POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 58
03613720210177POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 54
03613720210153POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 50
03613720210139POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 48
03613720210115POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 46
03613720210085POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 42
03613720210061POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 38
03613720210047POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 34
03613720210023POLYAXIAL CYLINDRICAL PEDICULAR SCREW 7.2 x 58
03613720210009POLYAXIAL CYLINDRICAL PEDICULAR SCREW 7.2 x 54
03613720209966POLYAXIAL CYLINDRICAL PEDICULAR SCREW 6.5 x 58
03613720209942POLYAXIAL CYLINDRICAL PEDICULAR SCREW 6.5 x 54
03613720209904TRANSVERSE LINK LARGE
03613720209898TRANSVERSE LINK MEDIUM
03613720209881TRANSVERSE LINK SMALL
03613720209867CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 48 to 62mm
03613720209843CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 34 to 48mm
03613720209829CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 22 to 34mm
03613720209812POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 11mm
036137202098059.3 MM LAMINAR LUMBAR HOOK FOR SHORT CLAW 9.3mm - Small
036137202097999.3 MM LAMINAR LUMBAR HOOK FOR LARGE CLAW 9.3mm - Large
03613720209782POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 9.3mm
03613720209775POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 7mm
03613720209737LAMINAR THORACIC HOOK FOR LARGE CLAW 7mm
03613720209720POLYAXIAL PEDICLE HOOK FOR CLAW 6mm
03613720209713POLYAXIAL PEDICLE HOOK FOR CLAW 4mm
036137202097068 MM LAMINAR LUMBAR OR TRANSVERSE HOOK FOR SHORT CLAW 8mm - Small
036137202096908 MM LAMINAR LUMBAR OR TRANSVERSE HOOK FOR LARGE CLAW 8mm - Large
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