Puresense Med

GUDID 08683105129443

STERILE GOWN

PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 08683105129443
• NIH Device Record Key: 6b51f6d3-0b04-49df-878f-7e47da8ae269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puresense Med
• Version Model Number: PSM104-XL
• Company DUNS: 533154912
• Company Name: PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08683105129443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093835

FDA Product Code

• FYA: Gown, 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: 2022-01-10
• Device Publish Date: 2021-12-31

On-Brand Devices [Puresense Med]

• 08683105129450: STERILE GOWN
• 08683105129443: STERILE GOWN
• 08683105129436: STERILE GOWN
• 08683105129429: STERILE GOWN
• 08683105129412: STERILE GOWN
• 08683105129351: STERILE GOWN
• 08683105129344: STERILE GOWN
• 08683105129337: STERILE GOWN
• 08683105129320: STERILE GOWN
• 08683105129313: STERILE GOWN