GPS

GUDID 00817800020516

PLEATED DUAL-FIT LEVEL 1 WHITE

GROUP PRACTICE SOLUTIONS INC.

Surgical/medical face mask, single-use

• Primary Device ID: 00817800020516
• NIH Device Record Key: 18c0fdf6-f412-4a8d-946e-0e2df9eafb14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GPS
• Version Model Number: 45-1503
• Company DUNS: 968188644
• Company Name: GROUP PRACTICE SOLUTIONS 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• 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	00817800020516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020474

FDA Product Code

• MSH: Respirator,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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-12-05

On-Brand Devices [GPS]

• 00817800020752: TEMPORARY CEMENT DUAL-BARREL SYRINGE NON-EUGENOL 6GM
• 00817800020660: ETCH GEL 37% 1.2ML SYRINGE 4/BX
• 00817800020653: BARRIER ENVELOPES SIZE 2
• 00817800020646: BARRIER ENVELOPES SIZE 1
• 00817800020639: DISPOSABLE LAB COAT - XX-LARGE
• 00817800020622: DISPOSABLE LAB COAT - X-LARGE
• 00817800020615: DISPOSABLE LAB COAT - LARGE
• 00817800020608: DISPOSABLE LAB COAT - MEDIUM
• 00817800020592: DISPOSABLE LAB COAT - SMALL
• 00817800020585: DISPOSABLE GOWNS TIE-BACK LARGE
• 00817800020578: DISPOSABLE GOWNS TIE-BACK MEDIUM
• 00817800020561: STERI-TUBING 6'' W/INDICATOR
• 00817800020554: STERI-TUBING 4'' W/INDICATOR
• 00817800020547: STERI-TUBING 3'' W/INDICATOR
• 00817800020530: STERI-TUBING 2'' W/INDICATOR
• 00817800020523: PLEATED MASK W/ SHIELD EAR-LOOP BLUE
• 00817800020516: PLEATED DUAL-FIT LEVEL 1 WHITE
• 00817800020509: PLEATED DUAL-FIT LEVEL 1 PINK
• 00817800020493: PLEATED DUAL-FIT LEVEL 1 BLUE
• 00817800020486: BITE REG. ''HARD'' FAST-SET 2 CART. W/TIPS
• 00817800020479: BARRIER ENVELOPES SIZE 0
• 90817800020427: BITE REG. SUPER FAST-SET MINT CC 2 CART. W/TIPS
• 90817800020410: BITE REG. FAST-SET MINT CC 2 CART. W/TIPS
• 90817800020403: BITE REG. SUPER FAST-SET 2 CART. W/TIPS
• 90817800020397: BITE REG. FAST-SET W/TIPS
• 90817800020380: BITE REG. REG-SET W/TIPS
• 90817800020366: PREMIUM MOLDED MASK PINK
• 90817800020342: PREMIUM MOLDED MASK BLUE
• 90817800020328: DIFFUSER EAR-LOOP MASK PINK
• 90817800020304: DIFFUSER EAR-LOOP MASK BLUE
• 90817800020281: BREATHE EZ EAR-LOOP PINK
• 90817800020267: BREATH-EZ PLEATED MASK BLUE
• 90817800020243: STERI-POUCHES DEFEND+ 13'' X 20''
• 90817800020229: STERI-POUCHES DEFEND+ 9'' X 15''
• 90817800020205: STERI-POUCHES DEFEND+ 7 1/2'' X 13''
• 90817800020182: STERI-POUCHES DEFEND+ 5 1/4'' X 10''
• 90817800020168: STERI-POUCHES DEFEND+ 3 1/2'' X 10''
• 90817800020144: STERI-POUCHES DEFEND+ 3 1/2'' X 10''
• 90817800020120: STERI-POUCHES DEFEND+ 3 1/2'' X 5 1/4''
• 90817800020106: STERI-POUCHES DEFEND+ 2 3/4'' X 10''
• 90817800020083: STERI-POUCHES DEFEND+ 2'' X 7 3/4''
• 90817800020069: STERI-POUCHES DEFEND+ 2 1/4'' X 2 2/3''
• 90817800020045: STERI-POUCHES DEFEND+ 2.25'' X 4''
• 90817800020038: AUTOCLAVE IND. TAPE 1''
• 90817800020021: AUTOCLAVE IND. TAPE 3/4''
• 90817800020014: AUTOCLAVE IND. TAPE 1/2''