Exact Medical Manufacturing Inc E5513G

GUDID 00850015378997

Microscope Drape, Leica, Bayonet, 137x381cm -54x150"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 00850015378997
• NIH Device Record Key: ddf63212-e850-42fc-a1af-83f774555677
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing Inc
• Version Model Number: E5513G
• Catalog Number: E5513G
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• 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: 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	00850015378980 [Primary]
GS1	00850015378997 [Package]; Contains: 00850015378980; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	00850024023000 [Package]; Package: Case [1 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: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [Exact Medical Manufacturing Inc]

• 00850015378256: Transducer Cover 18 x 147cm, Kit, VIP Film w/ Elastic Bands & EMM Gel
• 00850015378232: Transducer Cover 15 x 147cm, Kit, VIP Film w/ Elastic Bands & EMM Gel
• 00850015378577: Surgical Gown, XX Large, AAMI 4 HaloGuard
• 00850015378553: Surgical Gown, X Large, AAMI 4 HaloGuard
• 00850015378997: Microscope Drape, Leica, Bayonet, 137x381cm -54x150"
• 00816953023849: Microscope Drape, Zeiss MD,112x320cm - 44"x126"
• 00850015378942: Microscope Drape, Zeiss OPMI 51x165cm - 20"x65"