ANJON HOLDINGS 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

Component, Traction, Invasive (JEC) (10)

Premarket Exempt

Clear

Anjon Bremer Halo System - 00810592030145 Catalog Number : 100004

Device Description : Anjon Bremer Halo System Classic Vest, Petite/Slim (160cm and shorter) 26-34 in. (66-86cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030152 Catalog Number : 100005

Device Description : Anjon Bremer Halo System Classic Vest, Small (176cm and shorter) 32-38 in. (82-98cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030169 Catalog Number : 100006

Device Description : "Anjon Bremer Halo System Classic Vest, Large (176cm and taller) 36-42 in. (92-108cm)"

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030176 Catalog Number : 100007

Device Description : Anjon Bremer Halo System Classic Vest, Xlarge 42-58 in. (108-148cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030190 Catalog Number : AHT035H

Device Description : Anjon Bremer Halo System Crown, Small 19-23 in (48-58cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030206 Catalog Number : AHT036H

Device Description : Anjon Bremer Halo System Crown, Large 23-26 in (58-66cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030213 Catalog Number : APT021H

Device Description : Anjon Bremer Halo System Pediatric Ring, Small 15-16 in. (38-40cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030220 Catalog Number : APT022H

Device Description : Anjon Bremer Halo System Pediatric Ring, Large 17-19 1/2 in. (43-50cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030237 Catalog Number : 100014

Device Description : Anjon Bremer Halo System Pediatric Vest, Toddler 20-24 in. (50-62cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

Anjon Bremer Halo System - 00810592030244 Catalog Number : 100015

Device Description : Anjon Bremer Halo System Pediatric Vest, Child 22-28 in. (56-72cm)

Device Class : 2

Duns Number: 080902221

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 1

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