Exact Medical Manufacturing, Inc. EU000350

GUDID 26975085700634

Gown , PRF with 2 Towels , L , SMS

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use

• Primary Device ID: 26975085700634
• NIH Device Record Key: 0669599b-c28b-44d2-9be6-ad3f30b299a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing, Inc.
• Version Model Number: EU000350
• Catalog Number: EU000350
• 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	06975085700630 [Primary]
GS1	26975085700634 [Package]; Contains: 06975085700630; Package: Case [32 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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Exact Medical Manufacturing, Inc.]

• 06975085709183: Cover IID 168x60cm
• 16975424196183: Robotic assistant surgical cover
• 26975424196166: Sterile Cover with perforated tip 5" x 96"
• 16975424196480: C-Arm B Model Ziehm VI (6)
• 16975424196459: Cover IID 168x60cm
• 06975424193420: Multipurpose, Weighted Surgical Towel, Single
• 26975424196548: UNIVERSAL MINI C-ARM DRAPE
• 16975424196497: Probe Cover, Polyurethane
• 16975085701078: Drape 100x150cm, 2L
• 16975085701016: Drape, 200x150cm, PE
• 26975085700658: Gown , PRF with 2 Towels , XL , SMS
• 26975085700634: Gown , PRF with 2 Towels , L , SMS
• 06975085700531: Surgical Gown XX-Large Poly Reinforced
• 26975085700528: Surgical Gown X-Large Poly Reinforced
• 06975085700241: Gown , Standard with 2 Towels , L , SMS
• 26975085700221: Gown , Standard with 2 Towels , XL , SMS
• 26975085700184: Gown , Standard with 2 Towels , Large , Phoenix
• 26975424196531: Triple Wide Orange Cover
• 26975424196524: Double Wide Orange Cover
• 26975424195640: Drape for Zeiss Surgical Microscope w. LensGuard 54'' x 150"
• 16975424195537: 68mm Leica Lens M/S Four Oculars 54"x150" Angled Glass Lens
• 16975424195520: Leica MS Drape w/ Angled Glass Lens 54"x150"
• 16975424195513: Leica MS Drape w/ Angled Glass Lens 54"x120"
• 16975424195506: Microscope Drape for Zeiss MD 65mm Glass Lens, 54"x150"