FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EndoFlex Tips 29 guage, 21 mm
DI: 07540172010191
·
Model: 871200
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EndoFlex Tips 29 guage, 21 mm
- Primary DI
- 07540172010191
- Version / Model
- 871200
- Catalog Number
- 871200
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 2
- Public Version Date
- 2022-11-03
- Public Version Status
- Update
- Public Device Record Key
- 29b2e49d-3523-4f19-a95b-526e55b54f0f
- Distribution End Date
- 2022-11-02
Device Description
Dental material injection cannula, single-use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | 07540172010191 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 29 | Gauge | |
| Device Size Text, specify | 20 x 29Ga Tip |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius