MADISON 540286

GUDID 03607505402864

IMPLANET

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03607505402864
• NIH Device Record Key: ab9ebaae-ac21-4b07-87e6-396fc8f39310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MADISON
• Version Model Number: UC insert trial size 1 - 12mm
• Catalog Number: 540286
• Company DUNS: 291993439
• Company Name: IMPLANET
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607505402864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192084

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[03607505402864]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-23
• Device Publish Date: 2020-03-13

On-Brand Devices [MADISON]

• 03607503400480: Cemented CR femoral component S1 L
• 03607503403412: Cemented CR femoral component S8 R
• 03607503403405: Cemented CR femoral component S7 R
• 03607503403399: Cemented CR femoral component S6 R
• 03607503403382: Cemented CR femoral component S5 R
• 03607503403375: Cemented CR femoral component S4 R
• 03607503403368: Cemented CR femoral component S3 R
• 03607503403351: Cemented CR femoral component S2 R
• 03607503403344: Cemented CR femoral component S8 L
• 03607503403337: Cemented CR femoral component S7 L
• 03607503403320: Cemented CR femoral component S6 L
• 03607503403313: Cemented CR femoral component S5 L
• 03607503403306: Cemented CR femoral component S4 L
• 03607503403290: Cemented CR femoral component S3 L
• 03607503403283: Cemented CR femoral component S2 L
• 03607503400565: Cemented CR femoral component S1 R
• 03607503402743: Universal UC insert Size 8 - 20 mm
• 03607503402736: Universal UC insert Size 8 - 18 mm
• 03607503402729: Universal UC insert Size 8 - 16 mm
• 03607503402712: Universal UC insert Size 7 - 20 mm
• 03607503402705: Universal UC insert Size 7 - 18 mm
• 03607503402699: Universal UC insert Size 7 - 16 mm
• 03607503402682: Universal UC insert Size 6 - 20 mm
• 03607503402675: Universal UC insert Size 6 - 18 mm
• 03607503402668: Universal UC insert Size 6 - 16 mm
• 03607503402651: Universal UC insert Size 5 - 20 mm
• 03607503402644: Universal UC insert Size 5 - 18 mm
• 03607503402637: Universal UC insert Size 5 - 16 mm
• 03607503402620: Universal UC insert Size 4 - 20 mm
• 03607503402613: Universal UC insert Size 4 - 18 mm
• 03607503402606: Universal UC insert Size 4 - 16 mm
• 03607503402590: Universal UC insert Size 3 - 20 mm
• 03607503402583: Universal UC insert Size 3 - 18 mm
• 03607503402576: Universal UC insert Size 3 - 16 mm
• 03607503402569: Universal UC insert Size 2 - 20 mm
• 03607503402552: Universal UC insert Size 2 - 18 mm
• 03607503402545: Universal UC insert Size 2 - 16 mm
• 03607503402538: Universal UC insert Size 1 - 20 mm
• 03607503402521: Universal UC insert Size 1 - 18 mm
• 03607503402514: Universal UC insert Size 1 - 16 mm
• 03607503402262: Universal UC insert Size 8 - 14 mm
• 03607503402255: Universal UC insert Size 8 - 12 mm
• 03607503402248: Universal UC insert Size 8 - 10 mm
• 03607503402231: Universal UC insert Size 7 - 14 mm
• 03607503402224: Universal UC insert Size 7 - 12 mm
• 03607503402217: Universal UC insert Size 7 - 10 mm
• 03607503402200: Universal UC insert Size 6 - 14 mm
• 03607503402194: Universal UC insert Size 6 - 12 mm
• 03607503402187: Universal UC insert Size 6 - 10 mm
• 03607503402170: Universal UC insert Size 5 - 14 mm