FDA UDI
In Commercial Distribution
🇺🇸 United States
SafeGuide®
DI: 00816734021507
·
Model: 1214-02D
·
DIVERSATEK HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SafeGuide®
- Primary DI
- 00816734021507
- Version / Model
- 1214-02D
- Catalog Number
- 1214-02D
- Company Name
- DIVERSATEK HEALTHCARE, INC.
- Labeler DUNS
- 030650113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 5
- Public Version Date
- 2019-04-10
- Public Version Status
- Update
- Public Device Record Key
- e23c6c24-71ec-40e0-8b3b-4d7a35064bac
Device Description
Guidewire with Spring Tip - Single Use
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KNQ | Dilator, Esophageal | Gastroenterology, Urology | 876.5365 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 10816734021504 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00816734021507 | GS1 |
Customer Contacts
- Phone
- 800-558-6408
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 210 | Centimeter |