Identity
- Trade Name
- Painless Steel ® FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 25G 0.5 x 25 mm, short, RW (regular wall), hub and front cap red FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 162241 FDA UDI
- Primary DI / UDI-DI
- ETDG1622412 FDA UDI
- FDA Product Code
- DZM FDA UDI
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental syringe needle, single-use
Painless Steel ® by medmix Deutschland GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- medmix Deutschland GmbH
Sources (1)
- FDA UDI 1a3bb39c-a114-4e7c-ba65-14e0fc238150 34 fields · synced May 30, 2026