FDA UDI
In Commercial Distribution
🇺🇸 United States
XP-I SLA Fixture
DI: 08800041365128
·
Model: AIH2FM3513S
·
sewon medix Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XP-I SLA Fixture
- Primary DI
- 08800041365128
- Version / Model
- AIH2FM3513S
- Catalog Number
- AIH2FM3513S
- Company Name
- sewon medix Inc.
- Labeler DUNS
- 688731065
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-16
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 959b4799-b04c-49f5-b9c0-2de2584c1aa1
Device Description
SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45697 | Fixture/appliance dental drill bit, single-use | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800041365128 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153521 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius