PREFERRED MEDICAL PRODUCTS LLC PC-0338 AF-OE

GUDID 20680211003089

STERILE DISPOSABLE EQUIPMENT COVER - PROBE COVER 3" X 38" - ACCORDIAN FOLD W/ OPEN END

PREFERRED MEDICAL PRODUCTS, LLC

Patient surgical drape, single-use

• Primary Device ID: 20680211003089
• NIH Device Record Key: 14b45f97-acee-4ed3-8b5e-f72222c09fbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREFERRED MEDICAL PRODUCTS LLC
• Version Model Number: PC-0338 AF-OE
• Catalog Number: PC-0338 AF-OE
• Company DUNS: 161770292
• Company Name: PREFERRED MEDICAL PRODUCTS, LLC
• 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	00680211003085 [Primary]
GS1	20680211003089 [Package]; Contains: 00680211003085; Package: BOX [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863853

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [PREFERRED MEDICAL PRODUCTS LLC]

• 20680211003072: STERILE DISPOSABLE EQUIPMENT COVER - REMOTE CONTROL 8" X 10" WITH ADHESIVE, 1 MIL
• 20680211003089: STERILE DISPOSABLE EQUIPMENT COVER - PROBE COVER 3" X 38" - ACCORDIAN FOLD W/ OPEN END
• 10680211003099: STERILE DISPOSABLE EQUIPMENT COVER-SET UP COVER 24" X 65"- TAPE
• 10680211003112: STERILE DISPOSABLE EQUIPMENT COVER-CASE CART COVER 40" X 28" X 72"-SEWN
• 10680211003105: STERILE DISPOSABLE EQUIPMENT COVER-BAND BAG 20" X 20"- WITH DRAWSTRING
• 10680211003129: STERILE DISPOSABLE EQUIPMENT COVER- EAZY COVER 48" X 50"-BAND BAG
• 00680211003139: STERILE DISPOSABLE EQUIPMENT COVER- CART COVER 44" X 31" X 77"
• 10680211003150: STERILE DISPOSABLE EQUIPMENT COVER- 20" X 20" NO BAND BAG W/ POLY STRAP
• 40680211003144: STERILE DISPOSABLE .5" X 54" POLY STRAP
• 40680211003175: STERILE DISPOSABLE EQUIPMENT COVER- DOME COVER 36" X 100" - SEWN CLOSURE
• 10680211003167: STERILE DISPOSABLE EQUIPMENT COVER- EAZY COVER 40" X 12" - W/ BAND