FDA UDI
In Commercial Distribution
🇺🇸 United States
Truss Scanjig
DI: 08800155380789
·
Model: TS-2003
·
E-Pros Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Truss Scanjig
- Primary DI
- 08800155380789
- Version / Model
- TS-2003
- Company Name
- E-Pros Co., Ltd.
- Labeler DUNS
- 963196443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- 71bcc9e6-3b6c-41f1-9d4f-721cca4f8657
Device Description
Truss Scanjig - Straumann SRA 4.6 compatible Truss Scanbody
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61641 | Dental implant abutment analog, intraoral-scanning, single-use | An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800155380789 | GS1 |
Customer Contacts
- Phone
- +820535228778
- [email protected]