FDA UDI
Not in Commercial Distribution
🇺🇸 United States
tomas®
DI: J011302028000
·
Model: 302-028-00
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- tomas®
- Primary DI
- J011302028000
- Version / Model
- 302-028-00
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- dfc8f99e-305d-4c40-8756-7ce263878fcc
- Distribution End Date
- 2017-02-16
Device Description
tomas® anchorage system: tomas®-transfer cap
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 33592 | Orthodontic teeth positioner, preformed | A prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J011302028000 | HIBCC | ||||
| Unit of Use | J011302028001 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required