SUNMED, LLC

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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

Tube, Tracheal (W/Wo Connector) (BTR) (8) Ophthalmoscope, Battery-Powered (HLJ) (2)

Premarket Exempt

No Yes

Clear

Sunmed - 10889483041437 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 6.0mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041444 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 6.5mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041451 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 7.0mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041468 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 7.5mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041475 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 8.0mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041482 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 8.5mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041499 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 9.0mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483041505 Catalog Number :

Device Description : TRACH TUBE CUFFED SZ 9.5mm

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483042212 Catalog Number :

Device Description : Opthalmoscope Lamp 3.5V

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483042236 Catalog Number :

Device Description : Opthalmoscope Lamp 3.5V

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

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