RE-CUR PVA/ALP® 500012R

GUDID 00857910006833

RE-CUR PVA/ALP®1 - Garment (Reprocessed, Foot, Adult)

CURRIE MEDICAL SPECIALTIES INC.

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• Primary Device ID: 00857910006833
• NIH Device Record Key: 5a7c1e17-b8b3-4f16-b9de-f39a39407a25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE-CUR PVA/ALP®
• Version Model Number: RE-CUR PVA/ALP®1
• Catalog Number: 500012R
• Company DUNS: 079598595
• Company Name: CURRIE MEDICAL SPECIALTIES 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857910006338 [Primary]
GS1	00857910006833 [Package]; Contains: 00857910006338; Package: Case 10 Pr [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140092

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-05
• Device Publish Date: 2019-07-26

On-Brand Devices [RE-CUR PVA/ALP®]

• 00857910006840: RE-CUR PVA/ALP®2 - Garment (Reprocessed, Foot, Adult)
• 00857910006833: RE-CUR PVA/ALP®1 - Garment (Reprocessed, Foot, Adult)