GPS

GUDID 00817800020509

PLEATED DUAL-FIT LEVEL 1 PINK

GROUP PRACTICE SOLUTIONS INC.

Surgical/medical face mask, single-use
Primary Device ID00817800020509
NIH Device Record Keyddf92e15-016a-4671-b3b6-744b5baacb1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPS
Version Model Number45-1502
Company DUNS968188644
Company NameGROUP PRACTICE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817800020509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSHRespirator,Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2016-12-05

On-Brand Devices [GPS]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.