FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGERY NEEDLE LEFT N.0 RED
DI: 07640159160403
·
Model: 20228
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SURGERY NEEDLE LEFT N.0 RED
- Primary DI
- 07640159160403
- Version / Model
- 20228
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-21
- Public Version
- 2
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- 1053288f-7d27-46a8-a3ee-816424c7b79f
Device Description
N°1/L Red diam Ø 1.10 mm 8 POM plungers 1 NiTi cleaning curette
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EKI | Carrier, Amalgam, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35696 | Dental amalgam carrier | A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640159160403 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]