Microware Bone Plates and Bone Screws

GUDID 04719873055975

CORTEX SCREW 3.5mm x 38mm, HEXALOBULAR SOCKET, SELF-TAPPING, STAINLESS STEEL 316L

MICROWARE PRECISION CO., LTD.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04719873055975
• NIH Device Record Key: 2f50ab9b-7b47-4ed1-adf5-be6d0055f5d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microware Bone Plates and Bone Screws
• Version Model Number: 255038E-000
• Company DUNS: 658650833
• Company Name: MICROWARE PRECISION CO., LTD.
• 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: true
• 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: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw
• Phone: +886424636275
• Email: harrisondu@microware.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873055975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111008

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

Moist Heat or Steam Sterilization

[04719873055975]

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: 2016-09-05

On-Brand Devices [Microware Bone Plates and Bone Screws]

• 04719873092970: Hip Plate 145°, Barrel Length: 38mm, 16 Holes
• 04719873092963: Hip Plate 145°, Barrel Length: 38mm, 14 Holes
• 04719873092956: Hip Plate 145°, Barrel Length: 38mm, 12 Holes
• 04719873092949: Hip Plate 145°, Barrel Length: 38mm, 10 Holes
• 04719873092932: Hip Plate 145°, Barrel Length: 38mm, 6 Holes
• 04719873092925: Hip Plate 145°, Barrel Length: 38mm, 6 Holes
• 04719873092918: Hip Plate 145°, Barrel Length: 38mm, 5 Holes
• 04719873092901: Hip Plate 145°, Barrel Length: 38mm, 4 Holes
• 04719873092895: Hip Plate 145°, Barrel Length: 38mm, 3 Holes
• 04719873092888: Hip Plate 145°, Barrel Length: 38mm, 2 Holes
• 04719873092871: Hip Plate 140°, Barrel Length: 38mm, 16 Holes
• 04719873092864: Hip Plate 140°, Barrel Length: 38mm, 14 Holes
• 04719873092857: Hip Plate 140°, Barrel Length: 38mm, 12 Holes
• 04719873092840: Hip Plate 140°, Barrel Length: 38mm, 10 Holes
• 04719873092833: Hip Plate 140°, Barrel Length: 38mm, 8 Holes
• 04719873092826: Hip Plate 140°, Barrel Length: 38mm, 6 Holes
• 04719873092819: Hip Plate 140°, Barrel Length: 38mm, 5 Holes
• 04719873092802: Hip Plate 140°, Barrel Length: 38mm, 4 Holes
• 04719873092796: Hip Plate 140°, Barrel Length: 38mm, 3 Holes
• 04719873092789: Hip Plate 140°, Barrel Length: 38mm, 2 Holes
• 04719873092772: Hip Plate 135°, Barrel Length: 25mm, 6 Holes
• 04719873092765: Hip Plate 135°, Barrel Length: 25mm, 5 Holes
• 04719873092758: Hip Plate 135°, Barrel Length: 25mm, 4 Holes
• 04719873092741: Hip Plate 135°, Barrel Length: 25mm, 3 Holes
• 04719873092734: Hip Plate 135°, Barrel Length: 25mm, 2 Holes
• 04719873092727: Hip Plate 135°, Barrel Length: 38mm, 20 Holes
• 04719873092710: Hip Plate 135°, Barrel Length: 38mm, 18 Holes
• 04719873092703: Hip Plate 135°, Barrel Length: 38mm, 16 Holes
• 04719873092697: Hip Plate 135°, Barrel Length: 38mm, 14 Holes
• 04719873092680: Hip Plate 135°, Barrel Length: 38mm, 12 Holes
• 04719873092673: Hip Plate 135°, Barrel Length: 38mm, 10 Holes
• 04719873092666: Hip Plate 135°, Barrel Length: 38mm, 8 Holes
• 04719873092659: Hip Plate 135°, Barrel Length: 38mm, 6 Holes
• 04719873092642: Hip Plate 135°, Barrel Length: 38mm, 5 Holes
• 04719873092635: Hip Plate 135°, Barrel Length: 38mm, 4 Holes
• 04719873092628: Hip Plate 135°, Barrel Length: 38mm, 3 Holes
• 04719873092611: Hip Plate 135°, Barrel Length: 38mm, 2 Holes
• 04719873092604: Small T-Plate 3.5mm, Oblique Angled, 5 Holes
• 04719873092598: Small T-Plate 3.5mm, Oblique Angled, 4 Holes
• 04719873092581: Small T-Plate 3.5mm, Oblique Angled, 3 Holes
• 04719873056729: CORTEX SCREW 4.5mm x 54mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056712: CORTEX SCREW 4.5mm x 52mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056705: CORTEX SCREW 4.5mm x 50mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056699: CORTEX SCREW 4.5mm x 48mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056682: CORTEX SCREW 4.5mm x 46mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056675: CORTEX SCREW 4.5mm x 44mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056668: CORTEX SCREW 4.5mm x 42mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056651: CORTEX SCREW 4.5mm x 40mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056644: CORTEX SCREW 4.5mm x 38mm, HEXAGON SOCKET, Ti6Al4V
• 04719873056637: CORTEX SCREW 4.5mm x 36mm, HEXAGON SOCKET, Ti6Al4V