FDA UDI
In Commercial Distribution
🇺🇸 United States
Expasyl cannulas
DI: 03760243000751
·
Model: EXPASYL
·
ACTEON MANUFACTURING
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Expasyl cannulas
- Primary DI
- 03760243000751
- Version / Model
- EXPASYL
- Catalog Number
- 261015
- Company Name
- ACTEON MANUFACTURING
- Labeler DUNS
- 283473691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-09-20
- Public Version
- 3
- Public Version Date
- 2025-07-31
- Public Version Status
- Update
- Public Device Record Key
- 74309b35-4757-43c7-8eb9-c7a93def26a5
Device Description
Expasyl bended application cannulas x100 for EXPASYL paste (sulcular opening paste).
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVL | Cord, Retraction | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60366 | Dental material injection cannula, single-use | A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. 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 | 03760243009839 | GS1 | ||||
| Primary | 03760243000751 | GS1 |
Customer Contacts
- Phone
- +33(0)556349292
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050180 | 000 |