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) (9) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

Yes

Clear

NA - 00842307103318 Catalog Number :

Device Description : STRETCHER,EXTRA CARE BARIATRIC NO MATTRESS (LITTER PAD)

Device Class : 2

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

NA - 00842307103325 Catalog Number :

Device Description : WHEELCHAIR,34x22DP,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 - 00842307103349 Catalog Number :

Device Description : WHEELCHAIR,22"X18",DELUXE 450 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307103356 Catalog Number :

Device Description : WHEELCHAIR,28X22DP,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 - 00842307103363 Catalog Number :

Device Description : WHEELCHAIR,22X22DP,REM ARM,Q/R

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307103370 Catalog Number :

Device Description : WHEELCHAIR,22"X18",DELUXE 350 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307103387 Catalog Number :

Device Description : WHEELCHAIR,20X18,DELUXE 450 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307103394 Catalog Number :

Device Description : WHEELCHAIR,22"X18",DELUXE 350 LB CAPACITY

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307103400 Catalog Number :

Device Description : WHEELCHAIR,28X18DP,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 - 00842307103417 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

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