Future Generation Medical FGM-D0315

GUDID 16975424192246

Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 16975424192246
• NIH Device Record Key: 5aca78f2-1988-40fb-9347-db20b4c99b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Future Generation Medical
• Version Model Number: FGM-D0315
• Catalog Number: FGM-D0315
• 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	06975424192249 [Primary]
GS1	16975424192246 [Package]; Contains: 06975424192249; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	26975424192243 [Package]; Package: Case [4 Units]; In Commercial Distribution

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [Future Generation Medical]

• 16975424192406: Ophthalmic Drape w/ pouch 48" x 51", adhesive area 4" x 5"
• 16975424192253: Medium Drape w. Aperture 31" x 51"
• 16975424192246: Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture
• 16975424192093: "U-Drape, 48"" x 52"", U-Slot Aperture with Adhesive, Clear Plastic - Sterile"
• 26975424191697: Large PE Drape 17" x 23"
• 16975424191683: Small Towel Drape w. Adhesive Strip 17" x 11"