FDA UDI
In Commercial Distribution
🇺🇸 United States
Sticky Tim
DI: E22122481
·
Model: 2248
·
VOCO GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
70
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Basic Information
- Brand Name
- Sticky Tim
- Primary DI
- E22122481
- Version / Model
- 2248
- Catalog Number
- 2248
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2025-01-22
- Public Version
- 1
- Public Version Date
- 2025-01-30
- Public Version Status
- New
- Public Device Record Key
- 32ffbd3c-7991-4746-b794-ba19c3cb6d5c
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35697 | Dental material application tool, single-use | A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | E2212248 | HIBCC | ||||
| Primary | E22122481 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]