FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Single Use Surgical Professional
DI: 05055299102985
·
Model: S205
·
EAKIN SURGICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Surgical Professional
- Primary DI
- 05055299102985
- Version / Model
- S205
- Catalog Number
- S205
- Company Name
- EAKIN SURGICAL LIMITED
- Labeler DUNS
- 239505063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 4
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- 7bb31c8f-3bee-435c-8cff-c8a21dbd26ba
- Distribution End Date
- 2023-10-24
Device Description
Cushings Artery Forceps Curved 150mm
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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65449 | ENT foreign body extraction forceps | A hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also include a magnifying lens and/or light source. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055299102985 | GS1 | ||||
| Package | 05055299102978 | GS1 | Carton | 3 | Not in Commercial Distribution | 2023-10-24 |
Customer Contacts
- Phone
- +440292074740
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter |