Exact Medical Manufacturing Inc. E105170

GUDID 00850015378065

XXL AAMI 3 Non-Reinforced Surgical Gowns

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: 00850015378065
• NIH Device Record Key: d0538e37-e5a6-43fe-8269-dfa8b28d01f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing Inc.
• Version Model Number: E105170
• Catalog Number: E105170
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015378058 [Primary]
GS1	00850015378065 [Package]; Contains: 00850015378058; Package: Case [36 Units]; In Commercial Distribution

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: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [Exact Medical Manufacturing Inc.]

• 00850015378188: XXL Poly-reinforced Surgical Gown
• 00850015378164: XL Poly-reinforced Surgical Gown
• 00850015378140: Large Poly-reinforced Surgical Gown
• 00850015378102: XL Fabric Reinforced Surgical Gown
• 00850015378089: Large Fabric Reinforced Surgical Gown
• 00850015378065: XXL AAMI 3 Non-Reinforced Surgical Gowns
• 00850015378041: XL AAMI 3 Non-Reinforced Surgical Gown
• 00850015378027: Large AAMI 3 Non-Reinforced Surgical Gown
• 00816953024020: Microscope Drape, Zeiss MD,117x381cm - 46"x150"