FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551360460
·
Model: 28789GW
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551360460
- Version / Model
- 28789GW
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2019-02-23
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 2a9cb29d-70e0-409c-92ab-c91e9e985689
Device Description
Nitinol Guide Wire Ø 1.1 mm, 38.5 cm
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
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46690 | Gastro-urological guidewire, reusable | A metal coil or wire intended to 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551360460 | GS1 | ||||
| Unit of Use | 04048551115299 | GS1 |