FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: ETDG1620542
·
Model: 27G 0.4 x 32 mm, Luer Lock, single apical side vent, in sheath, hub medium grey
·
medmix Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- NA
- Primary DI
- ETDG1620542
- Version / Model
- 27G 0.4 x 32 mm, Luer Lock, single apical side vent, in sheath, hub medium grey
- Catalog Number
- 162054
- Company Name
- medmix Deutschland GmbH
- Labeler DUNS
- 314320603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-09-15
- Public Version
- 1
- Public Version Date
- 2024-09-23
- Public Version Status
- New
- Public Device Record Key
- 4ec43874-d86e-40a2-9b8e-2bd26d6cbd50
Device Description
Sterile Suction Needles (Endo Evacuation Needles) are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site during oral surgery. The device is a semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, irrigating solutions and water during a dental or oral procedure. Suction Needles are to be locked on a Luer Lock connection. It is not intended to penetrate tissue (it is not an injection needle). The cannula is made of stainless steel. 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 |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. 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 | ETDG162054 | HIBCC | ||||
| Primary | ETDG1620542 | HIBCC |