FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: ETDG1620692
·
Model: 30G 0.3 x 25 mm, Luer Lock, double side vent, closed end, in sheath, yellow
·
medmix Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- NA
- Primary DI
- ETDG1620692
- Version / Model
- 30G 0.3 x 25 mm, Luer Lock, double side vent, closed end, in sheath, yellow
- Catalog Number
- 162069
- Company Name
- medmix Deutschland GmbH
- Labeler DUNS
- 314320603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2023-01-26
- Public Version
- 1
- Public Version Date
- 2023-02-03
- Public Version Status
- New
- Public Device Record Key
- a277df51-ddc2-4618-adfa-3eac61d49399
Device Description
Sterile Irrigation Needles are used specifically for irrigation of the root canal of a tooth during an endodontic procedure and irrigation of periodontal pockets. Sterile endo irrigation needles are slender, hollow, tubular, metal instruments with a blunt tip. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. Endo irrigation needles are not designed for injection. This is a single-use device.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64403 | Root canal irrigation blunt needle | A slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. 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 | ETDG162069 | HIBCC | ||||
| Primary | ETDG1620692 | HIBCC |