E5315 Dome Bag 96x190cm - 38"x75" E5315

GUDID 00816953022163

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00816953022163
• NIH Device Record Key: 35d6e6ba-228c-47d6-82e7-44a38eeb9fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E5315 Dome Bag 96x190cm - 38"x75"
• Version Model Number: E5315
• Catalog Number: E5315
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816953021340 [Primary]
GS1	00816953021357 [Package]; Contains: 00816953021340; Package: Case [80 Units]; In Commercial Distribution
GS1	00816953022163 [Package]; Contains: 00816953021340; Package: Case [40 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-16

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