FDA UDI
In Commercial Distribution
🇺🇸 United States
4WEB Medical
DI: 00812998024643
·
Model: EOTS-SM1805
·
4web Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 4WEB Medical
- Primary DI
- 00812998024643
- Version / Model
- EOTS-SM1805
- Catalog Number
- EOTS-SM1805
- Company Name
- 4web Medical
- Labeler DUNS
- 021323706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-21
- Public Version
- 3
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 4ab56575-81fe-4775-af49-a2981175cb48
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61617 | Metallic osteotomy fusion cage, non-customized | A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812998024643 | GS1 |