Primary Device ID | 14251244500587 |
NIH Device Record Key | 8bb06cef-738b-4c85-aad8-c371b60ca3c9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biotronik Fortress Introducer Sheath System |
Version Model Number | 90 cm, 5F Straight |
Catalog Number | 444483 |
Company DUNS | 330926895 |
Company Name | Contract Medical International GmbH |
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 | true |
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 |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com | |
Phone | +410448645111 |
info.vi@biotronik.com |
Length | 90 Centimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Lumen/Inner Diameter | 1.95 Millimeter |
Length | 90 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04251244500580 [Primary] |
GS1 | 14251244500587 [Package] Contains: 04251244500580 Package: Packer [5 Units] In Commercial Distribution |
DYB | Introducer, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2018-11-30 |
14251244500600 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500594 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500587 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500570 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500563 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
04251244500559 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500099 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500082 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) |
14251244500075 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500068 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500051 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) |
14251244500044 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) |
14251244500037 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) |
04251244500023 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) |
14251244500013 | Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) |