FDA UDI
In Commercial Distribution
🇺🇸 United States
Van Sickle
DI: 00810207783756
·
Model: 34-155
·
VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Van Sickle
- Primary DI
- 00810207783756
- Version / Model
- 34-155
- Catalog Number
- NA
- Company Name
- VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED
- Labeler DUNS
- 183897771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-24
- Public Version
- 1
- Public Version Date
- 2025-12-02
- Public Version Status
- New
- Public Device Record Key
- 409c10a2-f569-4a66-9e89-00ff980fab79
Device Description
Cottle Nasal Speculum 6" (152) 70mm narrow tapered blades
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00810207783756 | GS1 |
Customer Contacts
- Phone
- 18176567100
- [email protected]