FDA UDI
In Commercial Distribution
🇺🇸 United States
FREE GLIDING SCFE SCREW SYSTEM
DI: 07540194008084
·
Model: SCF-GWS200
·
Pega Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FREE GLIDING SCFE SCREW SYSTEM
- Primary DI
- 07540194008084
- Version / Model
- SCF-GWS200
- Catalog Number
- SCF-GWS200
- Company Name
- Pega Medical Inc
- Labeler DUNS
- 257315713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 2
- Public Version Date
- 2021-03-26
- Public Version Status
- Update
- Public Device Record Key
- fee542e3-4103-44fb-a0ff-39f5ac00991b
Device Description
SCFE GUIDE WIRE SLEEVE - GENERATION II
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LHX | Trousers, anti-shock | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47831 | Orthopaedic implantation sleeve, reusable | A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540194008084 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 2.9 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep at room temperature