FDA UDI
In Commercial Distribution
🇺🇸 United States
Painless Steel ®
DI: ETDG1622392
·
Model: 27G 0.4 x 25 mm, short, RW (regular wall), hub and front cap yellow
·
medmix Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Painless Steel ®
- Primary DI
- ETDG1622392
- Version / Model
- 27G 0.4 x 25 mm, short, RW (regular wall), hub and front cap yellow
- Catalog Number
- 162239
- Company Name
- medmix Deutschland GmbH
- Labeler DUNS
- 314320603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- c870a03c-1265-4746-b527-b66b7553ef58
Device Description
Sterile Single-Use Dental Injection Needles are sterile, disposable, sharp bevel-edged, hollow tubular metal instruments with an integrated hub. Sterile Single-Use Dental Injection Needles should be used in combination with dental cartridge syringes (according to ISO 9997) in which a dental cylinder ampoule according to ISO 11040-1 is inserted.
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 |
|---|---|---|---|---|
| DZM | Needle, Dental | Dental | 872.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12740 | Dental syringe needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | ETDG1622394 | HIBCC | 50 | In Commercial Distribution | ||
| Primary | ETDG1622392 | HIBCC | ||||
| Unit of Use | ETDG162239 | HIBCC |