Humeral Plate, Distal 21244-8

GUDID 09120034304934

Humeral Plate, Distal, 8-Hole, Left, Medial

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034304934
• NIH Device Record Key: 5a1fc5a0-f4d8-42a6-91a0-7bfb6041fbf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humeral Plate, Distal
• Version Model Number: 21244-8
• Catalog Number: 21244-8
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• 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	09120034304934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080184

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

[09120034304934]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-08

On-Brand Devices [Humeral Plate, Distal]

• 09120047307069: Humeral Plate, Distal, 12-Hole, Left, Medial
• 09120047307038: Humeral Plate, Distal, 12-Hole, Right, Medial
• 09120034305337: Humeral Plate, Distal, 10-Hole, Left, Medial
• 09120034305320: Humeral Plate, Distal, 9-Hole, Left, Medial
• 09120034305313: Humeral Plate, Distal, 7-Hole, Left, Dorsolateral
• 09120034305306: Humeral Plate, Distal, 6-Hole, Left, Dorsolateral
• 09120034305290: Humeral Plate, Distal, 4-Hole, Left, Dorsolateral
• 09120034305283: Humeral Plate, Distal, 10-Hole, Right, Medial
• 09120034305276: Humeral Plate, Distal, 9-Hole, Right, Medial
• 09120034305269: Humeral Plate, Distal, 7-Hole, Right, Dorsolateral
• 09120034305252: Humeral Plate, Distal, 6-Hole, Right, Dorsolateral
• 09120034305245: Humeral Plate, Distal, 4-Hole, Right, Dorsolateral
• 09120034304934: Humeral Plate, Distal, 8-Hole, Left, Medial
• 09120034304927: Humeral Plate, Distal, 8-Hole, Right, Medial
• 09120034304910: Humeral Plate, Distal, 5-Hole, Left, Dorsolateral
• 09120034304903: Humeral Plate, Distal, 5-Hole, Right, Dorsolateral