GENDRON, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Chair, With Casters (INM) (5) Bed, Ac-Powered Adjustable Hospital (FNL) (4) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

Yes

Clear

NA - 00842307100317 Catalog Number :

Device Description : WHEELCHAIR,30X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100324 Catalog Number :

Device Description : WHEELCHAIR,32X20DP,REM ARM,Q/R750 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100331 Catalog Number :

Device Description : WHEELCHAIR,32X22DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100348 Catalog Number :

Device Description : WHEELCHAIR,26X20DP,REM ARM,Q/

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100355 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R850 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100362 Catalog Number :

Device Description : STRETCHER,ED/TRAUMA/PROCEDURE,28" HGT ADJ,TREND-REV. TREND

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100379 Catalog Number :

Device Description : BED,BARIATRIC ADJ 39x80 750LB 3 FUNCTION WIDTH & LENGTH ADJ92x52x32

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100386 Catalog Number :

Device Description : BED,BARIATRIC S/FRAME,39"x80" 3 FUNCTION,WIDTH & LENGTH ADJ750 LB CAPACITY

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100416 Catalog Number :

Device Description : BED, BARIATRIC EXPANDABLE LOW

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100423 Catalog Number :

Device Description : BED,BARIATRIC ADJ 39x80 750LB 3 FUNCTION WIDTH & LENGTH ADJ

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

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