ENDOTEC, INC.

Address:1501 N. Harbor blvd.,Fullerton,CA,92835,US

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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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (7) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (3)

Premarket Exempt

Clear

B-P TOTAL SHOULDER SYSTEM - 00814193025302 Catalog Number : 02-03-0048

Device Description : B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 48 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025319 Catalog Number : 02-03-0052

Device Description : B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 52 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025326 Catalog Number : 02-03-0056

Device Description : B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 56 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025333 Catalog Number : 02-04-0108

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 8 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025340 Catalog Number : 02-04-0110

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 10 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025357 Catalog Number : 02-04-0112

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 12 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025364 Catalog Number : 02-04-0114

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 14 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025371 Catalog Number : 02-04-0208

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 8 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025388 Catalog Number : 02-04-0210

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 10 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025395 Catalog Number : 02-04-0212

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 12 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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