n.a.
GUDID 04048551080542
Obturator only
Karl Storz GmbH & Co. KG
Suprapubic catheter introducer, reusable| Primary Device ID | 04048551080542 |
| NIH Device Record Key | bfb8b9a4-c50b-47b8-8451-6af76f8b0baa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | n.a. |
| Version Model Number | 27105O |
| Company DUNS | 315731430 |
| Company Name | Karl Storz GmbH & Co. KG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048551080542 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K943697
FDA Product Code
| ODB | endoscopic contamination prevention sheath |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
[04048551080542]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-05 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [n.a.]
| 04048551075623 | Working Element, bipolar |
| 04048551405116 | Articulated Arm, only |
| 04048551366967 | Mobile Stand for 28272 HS |
| 04048551322482 | Clamping Jaw, with ball joint, small |
| 04048551322475 | Clamping Jaw, with ball joint, large |
| 04048551313114 | Extension Rod, 50cm |
| 04048551175811 | BÜCHS Cheek Retractor, 20.5 cm |
| 04048551175637 | Elevator, width 8 mm, length 20 cm |
| 04048551175569 | Elevator, width 5 mm, length 20 cm |
| 04048551078150 | Pick 90°,bay., downwards, 1 mm, 18 cm |
| 04048551078143 | Pick 90°, bay., upwards, 1 mm, 18 cm |
| 04048551078105 | Pick 90°, bay., upwards, 0.5 mm, 18.5 cm |
| 04048551100080 | Elevator, 4mm, 19cm |
| 04048551365328 | Suction and Irrigation Tube |
| 04048551365304 | Suction and Irrigation Tube |
| 04048551337691 | Irrigation-Suction Sheath for 7230 AE |
| 04048551313848 | Irrigation Tube, 100K |
| 04048551313824 | Irrigation Tube for Handpiece |
| 04048551313695 | Irrigation Tube, 100K |
| 04048551313640 | Irrigation Tube, 60K |
| 04048551310793 | Suction and Irrigation Tube, 3 mm |
| 04048551310786 | Suction and Irrigation Tube, 3 mm |
| 04048551310779 | Suction and Irrigation Tube, 3 mm |
| 04048551288825 | TWINFlow Suction/Irrig. Tube, 4mm x 13cm |
| 04048551288801 | TWINFlow Suction/Irrig. Tube, 4mm x 9cm |
| 04048551288795 | TWINFlow Suction/Irrig. Tube, 2mm x 13cm |
| 04048551288788 | TWINFlow Suction/Irrig. Tube, 2mm x 9cm |
| 04048551279526 | Suction and Irrigation Tube, 13cm |
| 04048551279434 | WULLSTEIN Suction/Irrigation Tube, 13cm |
| 04048551279427 | Suction and Irrigation Tube, 15cm |
| 04048551267608 | Tappet, Ø 12 mm |
| 04048551267462 | Sleeve, Ø 12 mm |
| 04048551267455 | Sleeve, Ø 11 mm |
| 04048551267448 | Sleeve, Ø 9 mm |
| 04048551267431 | Sleeve, Ø 10 mm |
| 04048551267424 | Sleeve, Ø 8 mm |
| 04048551267417 | Sleeve, Ø 7 mm |
| 04048551267394 | Sleeve, Ø 6 mm |
| 04048551267387 | Tap |
| 04048551267363 | Sleeve, Ø 5 mm |
| 04048551267332 | Tappet, Ø 11 mm |
| 04048551267325 | Tappet, Ø 10 mm |
| 04048551267318 | Tappet, Ø 9 mm |
| 04048551267301 | Tappet, Ø 7 mm |
| 04048551267295 | Tappet, Ø 8 mm |
| 04048551267288 | Tappet, Ø 6 mm |
| 04048551267271 | Tappet, Ø 5 mm |
| 04048551258651 | Suction and Irrigation Tube |
| 04048551258125 | Irrigation and Suction tube, size 3 mm |
| 04048551194621 | Knurled ring, diameter 16 mm |
Trademark Results [n.a.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 N.A. 77965909 3968602 Live/Registered |
Okura USA, Inc. 2010-03-23 |
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