FDA UDI
In Commercial Distribution
🇺🇸 United States
GEO Bone Screw System
DI: B471270101500
·
Model: 27010150
·
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
- B471270101500
- Version / Model
- 27010150
- 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
- 3
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 4d2adb6b-9daf-4e49-9a6a-4a42d9d098b2
Device Description
Depth Gauge for 100mm/150mm K-Wires
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
- 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 |
|---|---|---|---|---|
| HTJ | GAUGE, DEPTH | Orthopedic | 888.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58796 | Surgical depth gauge, single-use | A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced; or 3) a cylindrical rod with markings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B471270101500 | HIBCC |
Customer Contacts
- Phone
- +1(855)436-2278
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161904 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius