Primary Device ID | 00814193022851 |
NIH Device Record Key | 1a4617e7-ffdb-4a67-9482-10c2d37ee13d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | B-P TOTAL HIP SYSTEM |
Version Model Number | 01-02-3264 |
Catalog Number | 01-02-3264 |
Company DUNS | 803488357 |
Company Name | ENDOTEC, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Lumen/Inner Diameter | 32 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Outer Diameter | 64 Millimeter |
Lumen/Inner Diameter | 32 Millimeter |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814193022851 [Primary] |
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-17 |
00814193024930 | B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 20 MM |
00814193024923 | B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 20 MM |
00814193024916 | B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 15 MM |
00814193024909 | B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 15 MM |
00814193024893 | B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 10 MM |
00814193024886 | B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 10 MM |
00814193024879 | B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 5 MM |
00814193024862 | B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 5 MM |
00814193024855 | B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 1 MM |
00814193024848 | B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM STD |
00814193024831 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 16 MM |
00814193024824 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 15 MM |
00814193024817 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 14 MM |
00814193024800 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 13 MM |
00814193024794 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 12 MM |
00814193024787 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 11 MM |
00814193024770 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 10 MM |
00814193024763 | B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 9 MM |
00814193024756 | B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 200 MM |
00814193024749 | B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 200 MM |
00814193024732 | B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 200 MM |
00814193024725 | B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 200 MM |
00814193024718 | B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 200 MM |
00814193024701 | B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 200 MM |
00814193024695 | B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 200 MM |
00814193024688 | B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 200 MM |
00814193024671 | B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 200 MM |
00814193024664 | B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 200 MM |
00814193024657 | B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 200 MM |
00814193024640 | B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 200 MM |
00814193024633 | B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 175 MM |
00814193024626 | B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 175 MM |
00814193024619 | B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 175 MM |
00814193024602 | B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 175 MM |
00814193024596 | B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 175 MM |
00814193024589 | B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 175 MM |
00814193024572 | B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 175 MM |
00814193024565 | B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 175 MM |
00814193024558 | B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 175 MM |
00814193024541 | B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 175 MM |
00814193024534 | B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 175 MM |
00814193024527 | B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 175 MM |
00814193024510 | B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 150 MM |
00814193024503 | B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 150 MM |
00814193024497 | B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 150 MM |
00814193024480 | B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 150 MM |
00814193024473 | B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 150 MM |
00814193024466 | B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 150 MM |
00814193024459 | B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 150 MM |
00814193024442 | B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 150 MM |