POSS Inc. E201602

GUDID 10852205007875

Drape, Sheet, bilam, 70" x 100"

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 10852205007875
• NIH Device Record Key: d206292a-80d7-450f-ad00-d9c4126b3257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POSS Inc.
• Version Model Number: E201602
• Catalog Number: E201602
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852205007878 [Primary]
GS1	10852205007875 [Package]; Contains: 00852205007878; Package: Case [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

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: 2017-04-25

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