FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Total-Comfort Blue Soft Tip Aspirators Clear Tubing
DI: 00723896009833
·
Model: K2900-TAS155TC
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Total-Comfort Blue Soft Tip Aspirators Clear Tubing
- Primary DI
- 00723896009833
- Version / Model
- K2900-TAS155TC
- Catalog Number
- 70-24910 CLE
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 2
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 2ada8463-3852-4fce-ad1d-00e51134d8f6
- Distribution End Date
- 2018-07-19
Device Description
ard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the mandible and aspirate tender tissue. Here is a truly comfortable solution-so comfortable, it's patented! Total-Comfort Soft Tip Aspirators feature cushioned, flexible, patient-friendly tips. Tested and proven to be gentle on soft tissue and bone while reducing soft tissue aspiration. Elastic tips are securely bonded for safety. 100% non-latex. 6" long. 100 aspirators per bag with white or clear tubing.
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
- No
- 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 |
|---|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896009840 | GS1 | Case | 10 | Not in Commercial Distribution | 2018-07-19 |
| Primary | 00723896009833 | GS1 | ||||
| Unit of Use | 00723896001158 | GS1 |