G & H WIRE COMPANY, INC.

Address:40 Linville Way,Franklin,IN,46131,US

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Device Description : REPLACEMENT PAD FOR ADJUSTABLE FACE MASK, M545-01

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : FACEMASK ADJUSTABLE

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : CHIN CUP WITH 2 PADS. REPLACEMENT PARTS FOR PROTRACTION FACEMASK.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : FOREHEAD PIECE REPLACEMENT PART FOR PROTRACTION FACEMASK.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : PROTRACTION FACE MASK (COMPLETE). The adaptability of this Protraction Face Mas PROTRACTION FACE MASK (COMPLETE). The adaptability of this Protraction Face Mask allows for directional force application by adjusting the elastics engagement bar to deliver protractive force in the desired plane. Fully adjustable forehead and chin rests allow for adaptation to most patient’s anatomical structure. The angle of traction is then determined by adjusting the elastics engagement bar to deliver horizontal, upward or downward forces as necessary. Includes Allen wrench and 3 sets of pads.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : REPLACEMENT PADS FOR PROTRACTION FACEMASK. Includes (2) forehead and (2) chin cup pads.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : REPLACEMENT CHIN CUP FOR REVERSE PULL FACEMASK (RPFMSM, OR RPFMLG)

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : The stainless steel frame is softened by hypo-allergenic chin and forehead pads The stainless steel frame is softened by hypo-allergenic chin and forehead pads to minimize irritation and maximize patient acceptance. Bilateral and bi-longitudinal adjust-ability allow for patient customization.Each mask also includes: 1 forehead pad, 2 chin pad and replacement screws.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : REPLACEMENT CHIN AND FORWARD PADS FOR REVERSE PULL FACEMASK (RPFMSM, OR RPFMLG)( REPLACEMENT CHIN AND FORWARD PADS FOR REVERSE PULL FACEMASK (RPFMSM, OR RPFMLG)(1) Chin Pad & (1) Forehead Pad

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Device Description : REPLACEMENT KEYS AND SCREWS FOR SMALL REVERSE PULL FACEMASK (RPFMSM)

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1