HeffMed Mini C-Arm Drape 52" x 72" Fluroscan HM-D800

GUDID 10850003355495

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile

• Primary Device ID: 10850003355495
• NIH Device Record Key: 68af2035-ec7b-466d-b220-4d24dbf7aa2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeffMed Mini C-Arm Drape 52" x 72" Fluroscan
• Version Model Number: HM-D800
• Catalog Number: HM-D800
• 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	00850003355498 [Primary]
GS1	10850003355495 [Package]; Contains: 00850003355498; Package: Case [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-19
• Device Publish Date: 2019-07-11

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