LIGAPASS

GUDID 03613720271277

LIGAPASS 2.0 BAND

MEDICREA INTERNATIONAL

Internal orthopaedic fixation system, cerclage wire/cable, sterile

• Primary Device ID: 03613720271277
• NIH Device Record Key: 9954069a-e378-478b-85ca-48b3e4be536c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIGAPASS
• Version Model Number: B08110005
• 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	03613720271277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173506

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

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: 2022-05-23
• Device Publish Date: 2018-04-17

On-Brand Devices [LIGAPASS]

• 03613720000457: SCREWDRIVER SHAFT T30
• 03613720271246: LIGAPASS 2.0 MEDIAL CONNECTOR
• 03613720271260: TENSION PULLEY SHAFT FOR MEDIAL CONNECTOR
• 03613720286783: LIGAPASS TENSION PULLEY HANDLE
• 03613720286578: T HANDLE-FIXED-1/4'' SQUARE
• 03613720286097: SHORT TENSION PULLEY SHAFT FOR MEDIAL CONNECTOR
• 03613720267454: SHORT TENSION PULLEY SHAFT FOR LIGAPASS LP CONNECTOR
• 03613720267447: SHORT TENSION PULLEY SHAFT FOR LIGAPASS CONNECTOR
• 03613720267430: LIGAPASS TENSION PULLEY HANDLE XS
• 03613720247197: TENSION PULLEY SHAFT FOR LIGAPASS 4.5 mm
• 03613720000631: LIGAPASS-BASE
• 03613720000624: LIGAPASS-LID
• 03613720000587: TENSION PULLEY SHAFT FOR LIGAPASS LP CONNECTOR
• 03613720000570: TENSION PULLEY SHAFT FOR LIGAPASS CONNECTOR
• 03613720000563: TENSION PULLEY HANDLE
• 03613720000549: TENSION PULLEY WITH STRAIN GAUGE
• 03613720000501: TORQUE LIMITER T-HANDLE
• 03613720000495: TORQUE LIMITER T-HANDLE
• 03613720000488: MEDIUM LIGAMENT PASSER
• 03613720000471: SMALL LIGAMENT PASSER
• 03613720000464: TORQUE LIMITER
• 03613720000440: TENSION PULLEY
• 03613720271284: LIGAPASS 2.0 DUAL BAND
• 03613720271277: LIGAPASS 2.0 BAND
• 03613720271253: LIGAPASS 2.0 MEDIAL OPEN CONNECTOR
• 03613720271239: LIGAPASS 2.0 MEDIAL CONNECTOR
• 03613720271222: LIGAPASS 2.0 MEDIAL OPEN CONNECTOR
• 03613720262282: LigaPASS CONNECTOR FOR Ø4.5 mm ROD
• 03613720248682: LigaPASS CONNECTOR FOR Ø4.5 mm ROD
• 03613720236726: LIGAPASS 2.0 DUAL BAND
• 03613720227267: LIGAPASS 2.0 OPEN CONNECTOR
• 03613720191995: LIGAPASS 2.0 OPEN CONNECTOR
• 03613720191971: LIGAPASS 2.0 CONNECTOR
• 03613720191964: LIGAPASS LP 2.0 CONNECTOR
• 03613720191902: LIGAPASS 2.0 CONNECTOR
• 03613720000372: LIGAPASS CONNECTOR
• 03613720000327: LIGAPASS CONNECTOR WITH PARALLEL LOCKINGS
• 03613720000310: LIGAPASS 2.0 CONNECTOR
• 03613720000303: LIGAPASS CONNECTOR
• 03613720000297: LIGAPASS 2.0 BAND
• 03613720000280: BAND