FDA UDI
In Commercial Distribution
🇺🇸 United States
maxi id-rings
DI: E29953610
·
Model: 5361
·
Polydentia SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- maxi id-rings
- Primary DI
- E29953610
- Version / Model
- 5361
- Company Name
- Polydentia SA
- Labeler DUNS
- 481461598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-07-05
- Public Version
- 1
- Public Version Date
- 2022-07-13
- Public Version Status
- New
- Public Device Record Key
- 6eeb035e-7e13-4626-a01f-b731dabce18e
Device Description
brown
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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47825 | Surgical instrument track identification tape | A non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). 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 | E29953619 | HIBCC | ||||
| Primary | E29953610 | HIBCC |
Customer Contacts
- Phone
- +41919462948
- [email protected]