FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Single Use Surgical Professional
DI: 05055299103104
·
Model: S211
·
EAKIN SURGICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Single Use Surgical Professional
- Primary DI
- 05055299103104
- Version / Model
- S211
- Catalog Number
- S211
- Company Name
- EAKIN SURGICAL LIMITED
- Labeler DUNS
- 239505063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 5
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- 6e50a7ad-8d2a-4294-a020-a585e5208f78
- Distribution End Date
- 2023-10-24
Device Description
Hudson Brace 265mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXY | Brace, Drill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32390 | Fluted surgical drill bit, reusable | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055299103104 | GS1 | ||||
| Package | 05055299103128 | GS1 | Carton | 3 | Not in Commercial Distribution | 2023-10-24 |
Customer Contacts
- Phone
- +440292074740
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 265 | Millimeter |