HeffMed HM-D830

GUDID 00850003355641

Mini C-Arm Drape, 12" II C-Arm Drape Kit with Clips

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850003355641
• NIH Device Record Key: c1aec832-d726-49fb-bac1-10e58c1654e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeffMed
• Version Model Number: HM-D830
• Catalog Number: HM-D830
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003355641 [Primary]
GS1	00850003355658 [Package]; Package: Case [20 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: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-09-11

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

• 16975424195988 - Exact Medical Manufacturing, Inc.: 2025-04-07 General Purpose Probe Cover (3D End), Gel, Bands 6" x 48"
• 16975424195995 - Exact Medical Manufacturing, Inc.: 2025-04-07 C-Arm Drape Miniview 6600/6800, 48 x 84"
• 06975424196001 - Exact Medical Manufacturing, Inc.: 2025-04-07 General Purpose Probe Cover 5" x 48" (13cm x 122cm)
• 16975424196015 - Exact Medical Manufacturing, Inc.: 2025-04-07 Intraoperative Probe Cover w/ Gel 5" x 96" (13cm x 244cm)
• 26975424196067 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Cover Mitaka MM51
• 26975424196074 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Drape For Zeiss OPMI 41" x 80"
• 16975424196084 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Drape- Zeiss MD 112x300cm - 44"x118"
• 26975424196098 - Exact Medical Manufacturing, Inc.: 2025-04-07 Intraoperative Large T-Shaped Probe Cover w/ Gel 6" x 96"