VBR™ vertebral body replacement CS 2220-2534-1

GUDID 04052536003549

VBR center piece, size A, Ø 20 mm, height 25-34 mm

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536003549
• NIH Device Record Key: 5df471cb-2994-4583-9b94-739466778815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBR™ vertebral body replacement
• Version Model Number: CS 2220-2534-1
• Catalog Number: CS 2220-2534-1
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536003549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003155

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536003549]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [VBR™ vertebral body replacement]

• 04052536076161: VBR end piece, size S, left, 8°
• 04052536076154: VBR end piece, size S, right, 5°
• 04052536076147: VBR end piece, size S, left, 5°
• 04052536076130: VBR end piece, size S, left, 0°
• 04052536076123: VBR end piece, size S, right, 0°
• 04052536076116: VBR center piece, size S, Ø 28 mm, height 82-130 mm
• 04052536076109: VBR end piece, size M, right, 8°
• 04052536076093: VBR end piece, size M, left, 8°
• 04052536076086: VBR end piece, size M, right, 5°
• 04052536076079: VBR end piece, size M, left, 5°
• 04052536076062: VBR end piece, size M, left, 0°
• 04052536076055: VBR end piece, size M, right, 0°
• 04052536076048: VBR center piece, size M, Ø 24 mm, height 74-114 mm
• 04052536004171: VBR end piece, size R, right, 8°
• 04052536004164: VBR end piece, size R, left, 8°
• 04052536004157: VBR end piece, size R, right, 5°
• 04052536004140: VBR end piece, size R, left, 5°
• 04052536004133: VBR end piece, size R, left, 0°
• 04052536004126: VBR end piece, size R, right, 0°
• 04052536004119: VBR center piece, size R, Ø 28 mm, height 56-84 mm
• 04052536004102: VBR end piece, size Q, right, 8°
• 04052536004096: VBR end piece, size Q, left, 8°
• 04052536004089: VBR end piece, size Q, right, 5°
• 04052536004072: VBR end piece, size Q, left, 5°
• 04052536004065: VBR end piece, size Q, left, 0°
• 04052536004058: VBR end piece, size Q, right, 0°
• 04052536004041: VBR center piece, size Q, Ø 28 mm, height 42-58 mm
• 04052536004034: VBR end piece, size P, right, 8°
• 04052536004027: VBR end piece, size P, left, 8°
• 04052536004010: VBR end piece, size P, right, 5°
• 04052536004003: VBR end piece, size P, left, 5°
• 04052536003990: VBR end piece, size P, left, 0°
• 04052536003983: VBR end piece, size P, right, 0°
• 04052536003976: VBR center piece, size P, Ø 28 mm, height 30-44 mm
• 04052536003891: VBR end piece, size L, right, 8°
• 04052536003884: VBR end piece, size L, left, 8°
• 04052536003877: VBR end piece, size L, right, 5°
• 04052536003860: VBR end piece, size L, left, 5°
• 04052536003853: VBR end piece, size L, left, 0°
• 04052536003846: VBR end piece, size L, right, 0°
• 04052536003839: VBR center piece, size L, Ø 24 mm, height 52-76 mm
• 04052536003822: VBR end piece, size K, right, 8°
• 04052536003815: VBR end piece, size K, left, 8°
• 04052536003808: VBR end piece, size K, right, 5°
• 04052536003792: VBR end piece, size K, left, 5°
• 04052536003785: VBR end piece, size K, left, 0°
• 04052536003778: VBR end piece, size K, right, 0°
• 04052536003761: VBR center piece, size K, Ø 24 mm, height 38-54 mm
• 04052536003754: VBR end piece, size H, right, 8°
• 04052536003747: VBR end piece, size H, left, 8°