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) (7) Bed, Ac-Powered Adjustable Hospital (FNL) (3)

Premarket Exempt

Yes

Clear

NA - 00842307100119 Catalog Number :

Device Description : BED,BARIATRIC S/FRAME,48x80

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100126 Catalog Number :

Device Description : BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITYBED ONLY

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100133 Catalog Number :

Device Description : BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITYINCLUDES POWER FIFTH BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITYINCLUDES POWER FIFTH WHEEL DRIVE

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

NA - 00842307100140 Catalog Number :

Device Description : WHEELCHAIR,22"X18",BASIC 350 LB CAPACITY REL03-01 01/17/03 WHEELCHAIR,22"X18",BASIC 350 LB CAPACITY REL03-01 01/17/03 EC03-08 3/25/03

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100157 Catalog Number :

Device Description : WHEELCHAIR,24X18,BASIC,BLACK NYLON 350 LB CAPACITY REL03-01 01/17 WHEELCHAIR,24X18,BASIC,BLACK NYLON 350 LB CAPACITY REL03-01 01/17/03 EC03-08 3/25/03

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100164 Catalog Number :

Device Description : WHEELCHAIR,24X18,BASIC 450 lb CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100171 Catalog Number :

Device Description : WHEELCHAIR,24"X18",DELUXE 350 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100188 Catalog Number :

Device Description : WHEELCHAIR,24"X18",DELUXE 450 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100195 Catalog Number :

Device Description : WHEELCHAIR,24X18DP,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 - 00842307100201 Catalog Number :

Device Description : WHEELCHAIR,24X18DP,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

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