FDA UDI
In Commercial Distribution
🇺🇸 United States
Traypurol Tabs
DI: E22123551
·
Model: 2355
·
VOCO GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Traypurol Tabs
- Primary DI
- E22123551
- Version / Model
- 2355
- Catalog Number
- 2355
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-06-06
- Public Version
- 2
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- 7b82cd2d-a3cd-422a-8179-1e01963514c2
Device Description
Active-tabs for cleaning trays and instruments.
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 |
|---|---|---|---|---|
| EHY | Tray, Impression, Preformed | Dental | 872.6880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63385 | Medical device cleaning agent | A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E22123551 | HIBCC | ||||
| Unit of Use | E2212355 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]