| Primary Device ID | B192300515000 |
| NIH Device Record Key | e04ed48d-a6fe-42cb-a3f2-c73d06ab9332 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IEC-Innoview GmbH |
| Version Model Number | 30-0515-00 |
| Catalog Number | 30-0515-00 |
| Company DUNS | 010741028 |
| Company Name | INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Angle | 30 degree |
| Outer Diameter | 4 Millimeter |
| Length | 302 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B192300515000 [Primary] |
| FAJ | Cystoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
[B192300515000]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-26 |
| B192300646000 | Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable |
| B192300515000 | 4 mm, 30deg. Cystoscope, autoclavable, L=302 mm, F.O.V. 70deg. |
| B192300514000 | Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 12deg., Lateral offset Eyepiece (Marberger), L=430 mm, |
| B192300495000 | 5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View |
| B192300494000 | 5 mm, 0 deg Laparoscope, L=300 mm, autoclavable, Large View |
| B192300428000 | 10 mm, 30 deg Laparoscope, L=339 mm, autoclavable, Laser welded |
| B192300427000 | 10 mm, 0 deg Laparoscope, L=339 mm, autoclavable, Laser welded |
| B192300421000 | 4.0 mm, 30 deg. Cystoscope, l=281.50mm, autoclavable, Olympus Compatible |
| B192300401000 | Bariatric 10 mm, 45 deg Laparoscope, L=425 mm, autoclavable |
| B192300348000 | 2.9 mm, 30 deg. Cystoscope, l=302mm, autoclavable |
| B192300346000 | 2.9 mm, 0 deg. Cystoscope, l=302mm, autoclavable |
| B192300311000 | 4.0 mm, 45 deg. Sinuscope, l=175mm, autoclavable |
| B192300083000 | 10.0 mm, 30 deg. Thoracoscope, l=170mm, autoclavable |
| B192300068000 | Semi-rigid Uretero Renoscope 7.5 / 8.5 Fr. 12 deg., Lateral offset Eyepiece (Marberger), L=430 m |
| B192300057000 | 4.0 mm, 30 deg. Cystoscope, l=302mm, autoclavable ( Cysto sheath ONLY-NOT Resectoscope/Working E |
| B192300055000 | 4.0 mm, 0 deg. Cystoscope, l=302mm, autoclavable |
| B192300054000 | 2.7 mm, 30 deg. Cystoscope, l=302mm, autoclavable |
| B192300043000 | 4.0 mm, 0 deg. Otoscope, l=50mm, autoclavable |
| B192300012000 | 4.0 mm, 70 deg. Arthroscope, l=175mm, autoclavable |
| B192300011000 | 4.0 mm, 30 deg. Arthroscope, l=175mm, autoclavable |
| B192300010000 | 4.0 mm, 0 deg. Arthroscope, l=175mm, autoclavable |
| B192300008000 | 2.7 mm, 30 deg. Arthroscope, l=187.5mm, autoclavable |
| B192300006000 | 2.7 mm, 70 deg. Arthroscope, l=175mm, autoclavable |
| B192300004000 | 2.7 mm, 0 deg. Arthroscope, l=175mm, autoclavable |
| B192300003000 | 2.7 mm, 70 deg. Arthroscope, l=110mm, autoclavable |
| B192300278000 | 8 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable |
| B192300049000 | 10 mm, 90 deg. Laryngoscope, l=190 mm, autoclavable |
| B192300048000 | 10 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable |