GUDID 38032248127402

Surgical Drape Kit

DELTA MED SPA

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 38032248127402
• NIH Device Record Key: c52cfcd0-2cd7-4019-b7f9-86f9b7c9fe0e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 12T7400
• Company DUNS: 444776777
• Company Name: DELTA MED SPA
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032248127401 [Primary]
GS1	38032248127402 [Package]; Contains: 08032248127401; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041080

FDA Product Code

• LRO: General Surgery Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-11-06
• Device Publish Date: 2016-09-23

Devices Manufactured by DELTA MED SPA

• 38032248007124 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007131 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007148 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007155 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007162 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007179 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007186 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007193 - SOL CARE T: 2021-04-07 I.V. Catheter with protector