FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551102268
·
Model: 26182TD
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551102268
- Version / Model
- 26182TD
- Catalog Number
- 26182TD
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-23
- Public Version
- 2
- Public Version Date
- 2024-07-29
- Public Version Status
- Update
- Public Device Record Key
- a841e6b6-9f96-4baf-99da-30a732a7997a
Device Description
Changing Rod, ø 2.9 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWW | Hysteroscope accessories | Obstetrics/Gynecology | 884.1690 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67280 | Endoscope sheath exchange guide | An invasive device in the form of a thin, rigid rod intended to provide guidance for exchanging one endoscope sheath, which has been introduced into a patient, for another (e.g., exchange a transvaginal diagnostic sheath with an operative sheath). It is intended to be inserted into the lumen of the initial sheath to guide sheath retraction and remain in situ to guide replacement sheath introduction; the guide is removed once the replacement sheath is in place. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551102268 | GS1 |
Customer Contacts
- Phone
- +14242188201
- [email protected]