FDA UDI
In Commercial Distribution
🇺🇸 United States
Cervical Plate
DI: B5231000750
·
Model: 100075-0
·
Eisertech, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cervical Plate
- Primary DI
- B5231000750
- Version / Model
- 100075-0
- Catalog Number
- 100075-0
- Company Name
- Eisertech, LLC
- Labeler DUNS
- 965627297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-07
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- eeb5769a-3b5a-4b07-901b-3d7c182517b9
Device Description
Fixed Drill Guide
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61573 | Orthopaedic fixation plate, non-bioabsorbable, non-sterile | A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B5231000750 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113170 | 000 |