PASS OCT

GUDID 03613720197492

SCREW-SCREW XLINK 21mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 03613720197492
• NIH Device Record Key: 14fd35cf-9077-4c16-8565-a598b9ce9a73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS OCT
• Version Model Number: B17160021S
• 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	03613720197492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150918

FDA Product Code

• NKG: Orthosis, Cervical Pedicle Screw Spinal Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-08
• Device Publish Date: 2015-10-23

On-Brand Devices [PASS OCT]

• 03613720220886: OCCIPITAL SCREWDRIVER SHAFT
• 03613720220879: OCCIPITAL AWL
• 03613720220862: Ø3.5mm ROD HOLDER
• 03613720220831: NUTDRIVER
• 03613720220824: PEDICLE SCREWDRIVER SHAFT
• 03613720220732: OCCIPITAL SCREWDRIVER
• 03613720220626: ROD HOLDER Ø3.5mm
• 03613720220596: SPEED DRIVER
• 03613720220565: NUT DRIVER
• 03613720220558: NUT HOLDER
• 03613720220497: PEDICLE SCREWDRIVER
• 03613720236306: PEDICLE SCREW Ø3.5 mm x 10 mm
• 03613720230601: DUAL DIAMETER ROD 3.5mm x 200mm / 6mm x 300mm
• 03613720230595: DUAL DIAMETER ROD 3.5mm x 200mm / 6mm x 300mm
• 03613720230588: DUAL DIAMETER ROD 3.5mm x 200mm / 5.5mm x 300mm
• 03613720230571: DUAL DIAMETER ROD 3.5mm x 200mm / 5.5mm x 300mm
• 03613720230557: SHANK SCREW Ø4mm x 50mm, 10mm THREADS
• 03613720230533: SHANK SCREW Ø4mm x 48mm, 10mm THREADS
• 03613720230519: SHANK SCREW Ø4mm x 46mm, 10mm THREADS
• 03613720230496: SHANK SCREW Ø4mm x 44mm, 10mm THREADS
• 03613720230472: SHANK SCREW Ø4mm x 42mm, 10mm THREADS
• 03613720230458: SHANK SCREW Ø4mm x 40mm, 10mm THREADS
• 03613720230434: SHANK SCREW Ø4mm x 38mm, 10mm THREADS
• 03613720230410: SHANK SCREW Ø4mm x 36mm, 10mm THREADS
• 03613720230397: SHANK SCREW Ø4mm x 34mm, 10mm THREADS
• 03613720230373: SHANK SCREW Ø4mm x 32mm, 10mm THREADS
• 03613720230359: SHANK SCREW Ø4mm x 30mm, 10mm THREADS
• 03613720230335: SHANK SCREW Ø4mm x 28mm, 10mm THREADS
• 03613720230311: SHANK SCREW Ø4mm x 26mm, 10mm THREADS
• 03613720230298: SHANK SCREW Ø4mm x 24mm, 10mm THREADS
• 03613720230274: SHANK SCREW Ø4mm x 22mm, 10mm THREADS
• 03613720230250: SHANK SCREW Ø4mm x 20mm, 10mm THREADS
• 03613720230236: SHANK SCREW Ø3.5mm x 50mm, 10mm THREADS
• 03613720230212: SHANK SCREW Ø3.5mm x 48mm, 10mm THREADS
• 03613720230199: SHANK SCREW Ø3.5mm x 46mm, 10mm THREADS
• 03613720230175: SHANK SCREW Ø3.5mm x 44mm, 10mm THREADS
• 03613720230151: SHANK SCREW Ø3.5mm x 42mm, 10mm THREADS
• 03613720230137: SHANK SCREW Ø3.5mm x 40mm, 10mm THREADS
• 03613720230113: SHANK SCREW Ø3.5mm x 38mm, 10mm THREADS
• 03613720230090: SHANK SCREW Ø3.5mm x 36mm, 10mm THREADS
• 03613720230076: SHANK SCREW Ø3.5mm x 34mm, 10mm THREADS
• 03613720230052: SHANK SCREW Ø3.5mm x 32mm, 10mm THREADS
• 03613720230038: SHANK SCREW Ø3.5mm x 30mm, 10mm THREADS
• 03613720230014: SHANK SCREW Ø3.5mm x 28mm, 10mm THREADS
• 03613720229995: SHANK SCREW Ø3.5mm x 26mm, 10mm THREADS
• 03613720229971: SHANK SCREW Ø3.5mm x 24mm, 10mm THREADS
• 03613720229957: SHANK SCREW Ø3.5mm x 22mm, 10mm THREADS
• 03613720229919: CoCr PRE BENT ROD Ø3.5mm x 120mm
• 03613720229896: CoCr PRE BENT ROD Ø3.5mm x 110mm
• 03613720229872: CoCr PRE BENT ROD Ø3.5mm x 100mm