PASS MED

GUDID 03613720208761

POLYAXIAL PEDICULAR CYLINDRICAL SCREW OFFSET 3mm 5,5 x 42

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720208761
• NIH Device Record Key: 31ff8680-2bbc-47c5-9c0b-707f429c5707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS MED
• Version Model Number: MS306C
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720208761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070530

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

[03613720208761]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-23
• Device Publish Date: 2015-10-23

On-Brand Devices [PASS MED]

• 03613720209744: LAMINAR THORACIC HOOK FOR SHORT CLAW 7mm - Small
• 03613720206613: PARALLEL CLOSED DOMINO
• 03613720206590: PARALLEL OPEN/CLOSED DOMINO
• 03613720235040: SACRAL SCREW Ø 7.2mm x 50mm
• 03613720235033: SACRAL SCREW Ø 7.2mm x 46mm
• 03613720235026: SACRAL SCREW Ø 7.2mm x 42mm
• 03613720235019: SACRAL SCREW Ø 7.2mm x 38mm
• 03613720235002: SACRAL SCREW Ø 7.2mm x 34mm
• 03613720234999: SACRAL SCREW Ø 6.5mm x 60mm
• 03613720234982: SACRAL SCREW Ø 6.5mm x 55mm
• 03613720234975: SACRAL SCREW Ø 6.5mm x 50mm
• 03613720234968: SACRAL SCREW Ø 6.5mm x 45mm
• 03613720234951: POLYAXIAL PEDICULAR CYLINDRICAL SCREW OFFSET 3mm 5,5 x 38
• 03613720225997: ROD FOR IN SITU BENDING Ø 6mm x 500mm
• 03613720225980: 48 TO 62 mm PLATE FOR CROSSLINK 48 to 62mm
• 03613720225973: 34 TO 48 mm PLATE FOR CROSSLINK 34 to 48mm
• 03613720225966: 22 TO 34 mm PLATE FOR CROSSLINK 22 to 34mm
• 03613720225959: CROSSLINK CONNECTOR
• 03613720210238: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 54
• 03613720210221: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 50
• 03613720210214: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 46
• 03613720210207: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 9 x 42
• 03613720210191: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 58
• 03613720210177: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 54
• 03613720210153: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 50
• 03613720210139: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 48
• 03613720210115: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 46
• 03613720210085: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 42
• 03613720210061: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 38
• 03613720210047: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 8 x 34
• 03613720210023: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 7.2 x 58
• 03613720210009: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 7.2 x 54
• 03613720209966: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 6.5 x 58
• 03613720209942: POLYAXIAL CYLINDRICAL PEDICULAR SCREW 6.5 x 54
• 03613720209904: TRANSVERSE LINK LARGE
• 03613720209898: TRANSVERSE LINK MEDIUM
• 03613720209881: TRANSVERSE LINK SMALL
• 03613720209867: CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 48 to 62mm
• 03613720209843: CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 34 to 48mm
• 03613720209829: CROSSLINK SYSTEM FOR Ø 6mm ROD - DISTANCES 22 to 34mm
• 03613720209812: POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 11mm
• 03613720209805: 9.3 MM LAMINAR LUMBAR HOOK FOR SHORT CLAW 9.3mm - Small
• 03613720209799: 9.3 MM LAMINAR LUMBAR HOOK FOR LARGE CLAW 9.3mm - Large
• 03613720209782: POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 9.3mm
• 03613720209775: POLYAXIAL LUMBAR LAMINAR HOOK FOR CLAW 7mm
• 03613720209737: LAMINAR THORACIC HOOK FOR LARGE CLAW 7mm
• 03613720209720: POLYAXIAL PEDICLE HOOK FOR CLAW 6mm
• 03613720209713: POLYAXIAL PEDICLE HOOK FOR CLAW 4mm
• 03613720209706: 8 MM LAMINAR LUMBAR OR TRANSVERSE HOOK FOR SHORT CLAW 8mm - Small
• 03613720209690: 8 MM LAMINAR LUMBAR OR TRANSVERSE HOOK FOR LARGE CLAW 8mm - Large