FDA UDI
In Commercial Distribution
🇺🇸 United States
COTTLE SEPTUM SPECULUM
DI: 00192896018440
·
Model: 16-2368
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COTTLE SEPTUM SPECULUM
- Primary DI
- 00192896018440
- Version / Model
- 16-2368
- Catalog Number
- 16-2368
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 2
- Public Version Date
- 2019-10-28
- Public Version Status
- Update
- Public Device Record Key
- 272f45f9-99f9-4e85-be67-6a8dfe0cdc27
Device Description
COTTLE SEPTUM SPECULUM WITH SCREW SET NARROW BLACK EBONY COATED BLADES
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", "Dry Heat Sterilization"]
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 |
|---|---|---|---|---|
| 35350 | Nasal speculum, reusable | A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896018440 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 35 Millimeter Blade | ||
| Length | 6 | Inch |