NEO SOOTHE POLYCHLOR PF SURG NATURAL 43670

GUDID D766436702

Smarthealth, Inc.

Polychloroprene surgical glove, non-powdered

• Primary Device ID: D766436702
• NIH Device Record Key: a97ead43-9b96-49b4-9f6c-9a8caf6464d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEO SOOTHE POLYCHLOR PF SURG NATURAL
• Version Model Number: 43670
• Catalog Number: 43670
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 25
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D766436700 [Unit of Use]
HIBCC	D766436701 [Primary]
HIBCC	D766436702 [Package]; Contains: D766436701; Package: case [4 Units]; In Commercial Distribution

FDA Product Code

• KGO: Surgeon'S Gloves

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: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [NEO SOOTHE POLYCHLOR PF SURG NATURAL]

• D766436852: 43685
• D766436800: 43680
• D766436752: 43675
• D766436702: 43670
• D766436652: 43665
• D766436602: 43660