SURGIPLUS 68-8508-G

GUDID 00683534090206

Procedure Mask Earloop Green ASTM Level 3, 50/BX,1000/CS, 25/25/25

A PLUS INTERNATIONAL INC.

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

• Primary Device ID: 00683534090206
• NIH Device Record Key: 27f71a0a-6b6b-4786-929c-1430c9bb9e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGIPLUS
• Version Model Number: 1
• Catalog Number: 68-8508-G
• Company DUNS: 191705904
• Company Name: A PLUS INTERNATIONAL 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00683534090206 [Package]; Contains: 00683534090213; Package: Inner Pack [50 Units]; In Commercial Distribution
GS1	00683534090213 [Primary]
GS1	80683534090202 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213001

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-11
• Device Publish Date: 2023-01-03

On-Brand Devices [SURGIPLUS]

• 00683534090084: PROCEDURE MASK FACE MASK WITH EARLOOP Green
• 00683534090060: PROCEDURE MASK FACE MASK WITH EARLOOP Green
• 00683534090183: Procedure Mask Earloop Green
• 00683534090169: Surgical Mask Tie-on Blue
• 00683534090152: Surgical Mask Tie-on Blue
• 00683534090121: PROCEDURE MASK WITH EARLOOP GREEN
• 00683534090107: PROCEDURE MASK FACE MASK WITH EARLOOP BLUE
• 70683534060550: P/E FILM GOWN BLUE;1/BG, 15 BG/BX, 5 BX/CS
• 70683534060543: P/E FILM GOWN BLUE;1/BG, 15 BG/BX, 5 BX/CS
• 00683534090220: Surgical Mask Tie-on Blue ASTM Level 3, 50/BX,1000/CS, 25/25/25
• 00683534090206: Procedure Mask Earloop Green ASTM Level 3, 50/BX,1000/CS, 25/25/25