StringKing

GUDID 30195376202217

3 Layer Surgical Mask, Level 3, Blue

String King Lacrosse LLC

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 30195376202217
• NIH Device Record Key: b3652a67-b60a-4c82-ab0c-ee4d491ae890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StringKing
• Version Model Number: 20221
• Company DUNS: 065807495
• Company Name: String King Lacrosse LLC
• Device Count: 50
• 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
GS1	00195376202216 [Primary]
GS1	00195376202230 [Unit of Use]
GS1	30195376202217 [Package]; Contains: 00195376202216; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202607

FDA Product Code

• FXX: Mask, Surgical

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: 2021-09-17
• Device Publish Date: 2021-09-09

On-Brand Devices [StringKing]

• 10195376202183: Disposable Surgical Gown - Level 3, XX-Large, Blue
• 30195376202163: Disposable Surgical Gown - Level 3, X-Large, Blue
• 30195376202149: Disposable Surgical Gown - Level 3, Medium, Blue
• 30195376202125: Disposable Surgical Gown - Level 3, Small, Blue
• 10195376202114: Disposable Surgical Gown - Level 3, Large, Blue
• 30195376202224: 3 Layer Surgical Mask, Level 3, White
• 30195376202217: 3 Layer Surgical Mask, Level 3, Blue
• 30195376202286: Disposable Surgical Gown - Level 4, XX-Large, Blue
• 30195376202279: Disposable Surgical Gown - Level 4, X-Large, Blue
• 30195376202262: Disposable Surgical Gown - Level 4, Large, Blue
• 30195376202255: Disposable Surgical Gown - Level 4, Medium, Blue
• 30195376202248: Disposable Surgical Gown - Level 4, Small, Blue
• 30195376202675: 3 Layer Surgical Mask, Level 2, White
• 30195376202668: 3 Layer Surgical Mask, Level 2, Blue
• 10195376201858: Disposable Isolation Gown, AAMI Level 2, SMS, Blue, X-Large
• 10195376201841: Disposable Isolation Gown, AAMI Level 2, SMS, Blue, Large