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Address:440 CHURCH ROAD,Avondale,PA,19311,US

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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

Accelerator, linear, medical (IYE) (7) SPLINT, NASAL (EPP) (3)

Premarket Exempt

No Yes

Clear

Fibreplast® Variable Perf™ with Integrated Shim™ - 10841962118016 Catalog Number : RT-A892KYSD

Device Description : Fibreplast VP Hd+Shldr Portrait S-Frame, 3.2mm Variable Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 5

Fibreplast® Variable Perf™ Assure™ Open View with Integrated Shim™ - 10841962118030 Catalog Number : RT-A892KYSDF

Device Description : Fibreplast Open View Hd+Shldr S-Frame 3.2mm Variable Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Fibreplast® Variable Perf™ Assure™ Open View with Integrated Shim™ - 10841962118047 Catalog Number : RT-A892KYSDF

Device Description : Fibreplast Open View Hd+Shldr S-Frame 3.2mm Variable Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 5

Aquaplast RT™ with Integrated Shim™ - 10841962118061 Catalog Number : RT-A892SD

Device Description : Aquaplast RT Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Aquaplast RT™ with Integrated Shim™ - 10841962118078 Catalog Number : RT-A892SD

Device Description : Aquaplast RT Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 5

Aquaplast RT™ Variable Perf™ with Integrated Shim™ - 10841962118092 Catalog Number : RT-A892YSD

Device Description : Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm Variable Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Aquaplast RT™ Variable Perf™ with Integrated Shim™ - 10841962118108 Catalog Number : RT-A892YSD

Device Description : Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm Variable Perf w/ Integrated Shim

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 5

Aquaplast PS™ - 10841962118122 Catalog Number : PS-1300

Device Description : Blush, 1/16" - 3" x 3" Nasal Splint Blanks

Device Class : 1

Duns Number: 808875397

Premarket Exempt : Yes

Product Code : EPP

Prescription Use : Yes

Device Count : 10

Aquaplast PS™ - 10841962118146 Catalog Number : PS-1302

Device Description : Blush, 1/16" Small Silver splint, pkg. of 10

Device Class : 1

Duns Number: 808875397

Premarket Exempt : Yes

Product Code : EPP

Prescription Use : Yes

Device Count : 10

Aquaplast PS™ - 10841962118160 Catalog Number : PS-1304

Device Description : Blush, 1/16" Large Silver splint, pkg. of 10

Device Class : 1

Duns Number: 808875397

Premarket Exempt : Yes

Product Code : EPP

Prescription Use : Yes

Device Count : 10

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