FDA UDI
In Commercial Distribution
🇺🇸 United States
Laser-Vocal cord spreader
DI: 04250676742797
·
Model: 50-652-23-L
·
Spiggle & Theis Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Laser-Vocal cord spreader
- Primary DI
- 04250676742797
- Version / Model
- 50-652-23-L
- Catalog Number
- 50-652-23-L
- Company Name
- Spiggle & Theis Medizintechnik GmbH
- Labeler DUNS
- 332893028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-19
- Public Version
- 1
- Public Version Date
- 2025-09-29
- Public Version Status
- New
- Public Device Record Key
- b411f848-19c8-4d98-8cb2-f0cf90cea211
Device Description
cylindrical shaft, with ratchet irrigation channel, 2.0 mm, 26.5 cm
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35009 | Over-guidewire oesophageal dilator | A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities. Commonly known as a Savary-Guillard dilator it will typically be used during fluoroscopy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250676742797 | GS1 |
Customer Contacts
- Phone
- +492206908165
- [email protected]