FDA UDI
In Commercial Distribution
🇺🇸 United States
Optimos™ Guidewire
DI: 08809744979977
·
Model: GW2-45A
·
TAEWOONGMEDICAL.CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Optimos™ Guidewire
- Primary DI
- 08809744979977
- Version / Model
- GW2-45A
- Catalog Number
- GW2-45A
- Company Name
- TAEWOONGMEDICAL.CO.,LTD
- Labeler DUNS
- 689484322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-04
- Public Version
- 2
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- 845a5d17-34bf-40af-84ba-3592fe777ad1
Device Description
The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46691 | Gastro-urological guidewire, single-use | A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08809909404047 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 08809744979977 | GS1 |
Customer Contacts
- Phone
- 323-692-0028
- [email protected]
- Phone
- +82319960641
- [email protected]