OSIS Medical OS1000HC

GUDID 26975424195541

OSIS DRAPE - LEICA MICROSCOPE - HANDLES - 5"X10"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 26975424195541
• NIH Device Record Key: 8075e07d-a0de-4fd4-9f25-5d4ad7028b86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSIS Medical
• Version Model Number: OS1000HC
• Catalog Number: OS1000HC
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424195547 [Primary]
GS1	26975424195541 [Package]; Contains: 06975424195547; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [OSIS Medical]

• 16975424195575: OSIS DRAPE - LEICA MICROSCOPE - MINI - 46"X80"
• 16975424195568: OSIS DRAPE - LEICA MICROSCOPE - MEDIUM - 46"X120"
• 16975424195551: OSIS DRAPE - LEICA MICROSCOPE - LARGE - 54"X150"
• 26975424195541: OSIS DRAPE - LEICA MICROSCOPE - HANDLES - 5"X10"