PDC

GUDID 00850031271838

Mini C-arm Drape 48" x 84"

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 00850031271838
• NIH Device Record Key: 65d36327-7433-4159-8382-d46912f70c1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDC
• Version Model Number: CAC03
• 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	00850031271821 [Primary]
GS1	00850031271838 [Package]; Contains: 00850031271821; Package: Case [25 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [PDC]

• 00850031271890: C-Arm Drape with Clips 41x215cm - 16"x85"
• 00850031271876: C-arm Cover Mini Kit
• 00850031271852: C-Arm Drape 104x188cm - 42" x 74"
• 00850031271838: Mini C-arm Drape 48" x 84"
• 00850031271814: Mini C-Arm Drape 52"x72" Fluroscan
• 00850031271791: C-Arm Kit Sterile 12" II
• 00850033380002: Foot Pedal Drape 17"x15"
• 00850031271982: Band Bag with tape 91x76cm - 36"x30"