GENDRON, INC.

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

Stretcher, Wheeled (FPO) (6) Bed, Ac-Powered Adjustable Hospital (FNL) (3) Chair, With Casters (INM) (1)

Premarket Exempt

Yes

Clear

NA - 00842307100003 Catalog Number :

Device Description : STRETCHER,NON MAG,SS

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100010 Catalog Number :

Device Description : STRETCHER,CHR FRM,ENAM LTR

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100027 Catalog Number :

Device Description : STRETCHER,CHR FRM,ENAM LTR

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100034 Catalog Number :

Device Description : STRETCHER,CHR FRM,ENAM LTR, UTILITY SHELF

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100041 Catalog Number :

Device Description : STRETCHER,BARIATRIC TRANSPORT WITH HYD. FOWLER

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100058 Catalog Number :

Device Description : STRETCHER,EXTRA CARE BARIATRICCO153 3/6/07

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307100065 Catalog Number :

Device Description : BED, ECONOMY LTC BARIATRIC LOW, S/FRAMEWIDTH EXPANDABLE; 36", 42", AND 48"84" D BED, ECONOMY LTC BARIATRIC LOW, S/FRAMEWIDTH EXPANDABLE; 36", 42", AND 48"84" DECK LENGTH3-FUNCTION HANDSET850 LB. CAPACITYHEAD END SIDERAILS

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100072 Catalog Number :

Device Description : BED,HOMECARE 42 X 86" 650 LB 3 FUNCTION BEECHWOOD FRAME,DECORATIVE STYLE HEAD BED,HOMECARE 42 X 86" 650 LB 3 FUNCTION BEECHWOOD FRAME,DECORATIVE STYLE HEADBOARD/FOOTBOARD OF CHOCOLATE PEAR COLOR,FULL PLASTIC SIDERAILS (HEAD END ONLY),FOOT END CONTROLS ON FOOTBOARD FOR BACKREST, LEG, BED, UP AND DOWN. ALSO LOCKOUTS FOR ANY OR ALL FUNCTIONS.

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100096 Catalog Number :

Device Description : BED,HOMECARE 48X84" 650 LB 3 FUNCTIONBEECHWOOD

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100102 Catalog Number :

Device Description : WHEELCHAIR,MR,20",SPORTLITE,SS WEIGHT LIMIT 350lb

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

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