FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ERA Implant® Surgical Kit, Complete
DI: 00841549114526
·
Model: 905119
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ERA Implant® Surgical Kit, Complete
- Primary DI
- 00841549114526
- Version / Model
- 905119
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-07
- Public Version
- 2
- Public Version Date
- 2020-08-10
- Public Version Status
- Update
- Public Device Record Key
- 8e349f9e-346d-4a53-bb80-6797645be789
- Distribution End Date
- 2020-08-07
Device Description
The ERA Implant Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45145 | Dental/maxillofacial surgical procedure kit, medicated, reusable | A collection of various dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841549114526 | GS1 |
Customer Contacts
- Phone
- 5082265660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041271 | 000 |