FDA UDI
In Commercial Distribution
🇺🇸 United States
Dispensing Tips
DI: 10841396101448
·
Model: 450120
·
Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Dispensing Tips
- Primary DI
- 10841396101448
- Version / Model
- 450120
- Catalog Number
- 450120
- Company Name
- Kerr Corporation
- Labeler DUNS
- 199354556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 6
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- d9141d85-0fbe-43fd-b623-aba3665cd417
Device Description
Dispensing Tips 20 Gauge, 100 PK; Refill
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
- 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 | 10841396101448 | GS1 | ||||
| Unit of Use | 00841396101441 | GS1 |
Customer Contacts
- Phone
- +18005377123
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20 Gauge Dispensing Tip |