FDA UDI
Not in Commercial Distribution
🇺🇸 United States
X-RAY FOOT/LEG SECTION
DI: 10841736112950
·
Model: 5-010-02-4B
·
SKYTRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- X-RAY FOOT/LEG SECTION
- Primary DI
- 10841736112950
- Version / Model
- 5-010-02-4B
- Company Name
- SKYTRON LLC
- Labeler DUNS
- 078375583
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-15
- Public Version
- 2
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- e80194a2-2ace-416d-ba6c-c09c61b5a60e
- Distribution End Date
- 2025-02-05
Device Description
3/8" X-RAY FT/LEG SECTION WITH CUT OUT
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37255 | Universal operating table top | A component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841736112950 | GS1 |
Customer Contacts
- Phone
- 800-759-8766
- [email protected]