FDA UDI
In Commercial Distribution
🇺🇸 United States
MENTIO Disposable Nasal Specula
DI: 04250676734914
·
Model: 5002002
·
Spiggle & Theis Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MENTIO Disposable Nasal Specula
- Primary DI
- 04250676734914
- Version / Model
- 5002002
- Catalog Number
- 5002002
- Company Name
- Spiggle & Theis Medizintechnik GmbH
- Labeler DUNS
- 332893028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- 093d4708-a9e9-4fee-92bf-7eb7ddad9d9b
Device Description
large, black, plastic (polyamid) 25 pieces/box
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EPY | SPECULUM, ENT | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42449 | Nasal speculum, single-use | A hand-held surgical instrument which is inserted into a nostril and manually expanded to open the nostril to a maximum by stretching the tissue around the nasal orifice allowing the doctor or surgeon access for examination or surgery during ear/nose/throat (ENT) intervention. It is made of disposable materials and has two blunt, contoured blades that are operated by the operator applying pressure to the pivoted handles or other mechanism. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250676734914 | GS1 |
Customer Contacts
- Phone
- +492206908165
- [email protected]