Exact Medical Manufacturing Inc E104060

GUDID 00850015378553

Surgical Gown, X Large, AAMI 4 HaloGuard

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 00850015378553
• NIH Device Record Key: 3152de7a-d500-4436-96d1-3ae52d060e2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing Inc
• Version Model Number: E104060
• Catalog Number: E104060
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015378546 [Primary]
GS1	00850015378553 [Package]; Contains: 00850015378546; Package: case [44 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120045

FDA Product Code

• FYA: Gown, 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: 2020-04-17
• Device Publish Date: 2020-04-09

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"