FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpine Stirrups, Metric, Left
DI: 00841962120548
·
Model: RT-5100-54L-CE
·
Qfix
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alpine Stirrups, Metric, Left
- Primary DI
- 00841962120548
- Version / Model
- RT-5100-54L-CE
- Catalog Number
- RT-5100-54L-CE
- Company Name
- Qfix
- Labeler DUNS
- 808875397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 6ec86e04-a884-4fe7-b05b-67bfb700e09b
Device Description
Alpine Stirrups, Metric, Left
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IZI | System, X-Ray, Angiographic | Radiology | 892.1600 | 2 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | Radiology | 892.1200 | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11991 | Heel stirrup | A device used during a medical/surgical procedure to steadily hold a patient's foot (feet) by cradling the heel. It is typically attached to an operating table, examination table, or treatment chair and is considered an accessory to these devices. This device is typically constructed of metal and plastic and used in pairs mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841962120548 | GS1 |
Customer Contacts
- Phone
- +1 712-737-8688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230312 | 000 |