FDA UDI
In Commercial Distribution
🇺🇸 United States
GEO Bone Screw System
DI: B471711300030
·
Model: 71130003
·
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GEO Bone Screw System
- Primary DI
- B471711300030
- Version / Model
- 71130003
- Company Name
- GRAMERCY EXTREMITY ORTHOPEDICS LLC
- Labeler DUNS
- 080068420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-10
- Public Version
- 1
- Public Version Date
- 2018-11-12
- Public Version Status
- New
- Public Device Record Key
- f0aadeb4-f308-45fa-a8c0-44c83919bcc2
Device Description
K-Wire Pack (2) 1.6mmx100mm for 4mm/5mm Bone Screw
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KDD | Kit, surgical instrument, disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B471711300030 | HIBCC |
Customer Contacts
- Phone
- +1(855)436-2278
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161904 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius