Identity
- Trade Name
- 2-PART DENTSPLY FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- 2 ML (3 ML) 2-PART DENTSPLY LUER LOCK FDA UDI
- Model / Reference
- 8300006569 FDA UDI
- Description
- 2 ML (3 ML) 2-PART DENTSPLY LUER LOCK FDA UDI
Identifiers
- Catalog Number
- 8300006569 FDA UDI
- Primary DI / UDI-DI
- 04035873028567 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe
2-Part Dentsply by Henke-Sass, Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metered-delivery hypodermic syringe.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (1)
- FDA UDI 3a22a3f2-1fc7-4af4-9915-3c1d3b7cc079 36 fields · synced May 30, 2026