Exact Medical Medical Inc. E105270

GUDID 00850015378126

XXL Fabric Reinforced Surgical Gowns

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use

• Primary Device ID: 00850015378126
• NIH Device Record Key: e5c10516-7ec3-4b6b-a1dc-c65c53999562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Medical Inc.
• Version Model Number: E105270
• Catalog Number: E105270
• 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	00850015378119 [Primary]
GS1	00850015378126 [Package]; Contains: 00850015378119; Package: Case [28 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

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

• 00850015378331 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
• 00850015378355 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 12x100cm with tape closure
• 00850015378386 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x120cm with tape closure
• 00850015378416 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x100cm with tape closure
• 00850015378447 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 20x110cm with tape closure
• 00850015378478 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x90cm with tape closure
• 00850015378591 - Exact Medical Manufacturing Inc: 2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
• 00850024023666 - Exact Medical: 2024-07-25 Band Bag with tape 122x65cm - 48"x26"