n.a.
- Primary DI
- 04048551053591
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 12070
- Device description
- Handle, for esophagoscopes
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EOX | ESOPHAGOSCOPE (FLEXIBLE OR RIGID) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551053591 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551053591 | 04048551053591 | 4048551053591 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical instrument handle, non-torque-limiting | A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Peracetic Acid;Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide |
Regulatory Flags
- DUNS number
- 315731430
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04048551232378 | n.a. | 27033U | 27033U | 2025-08-11 |
| 04048551232781 | n.a. | 27047B | 27047B | 2025-08-11 |
| 04048551418123 | n.a. | TC304US | TC304US | 2025-08-11 |
| 04048551210567 | n.a. | 8574GY | 8574GY | 2018-09-04 |
| 04048551210574 | n.a. | 8574GZ | 8574GZ | 2018-09-04 |
| 04048551211281 | n.a. | 8587K | 8587K | 2018-09-04 |
| 04048551211427 | n.a. | 8588K | 8588K | 2018-09-04 |
| 04048551211694 | n.a. | 8590KC | 8590KC | 2018-09-04 |
| 04048551425749 | n.a. | 40410LH | 40410LH | 2025-07-10 |
| 04048551425756 | n.a. | 40410LS | 40410LS | 2025-07-10 |
| 04048551425763 | n.a. | 40410LG | 40410LG | 2025-07-10 |
| 04048551425770 | n.a. | 40410LC | 40410LC | 2025-07-10 |
| 04048551425787 | n.a. | 40410LL | 40410LL | 2025-07-10 |
| 04048551425794 | n.a. | 40410LF | 40410LF | 2025-07-10 |
| 04048551425800 | n.a. | 40410LR | 40410LR | 2025-07-10 |
| 04048438008867 | NA | 051111-10 | 051111-10 | 2025-03-28 |
| 04048438008911 | NA | 051110-10 | 051110-10 | 2025-03-28 |
| 04048551010242 | NA | 497HCS | 497HCS | 2025-03-28 |
| 04048551012468 | NA | 11900RA | 11900RA | 2025-03-28 |
| 04048551061343 | NA | 20090331 | 20090331 | 2025-03-28 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04048551178515 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551178539 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551178546 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190098 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190104 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190111 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551001387 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551001493 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551001974 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047675 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047811 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047828 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047866 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047873 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047897 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047903 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047941 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047989 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047996 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551048641 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551048658 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551068762 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551068786 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069615 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069639 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069653 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069677 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069714 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069738 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551069752 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |