FDA UDI
In Commercial Distribution
🇺🇸 United States
Quala
DI: D023Q90371
·
Model: Q9037
·
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Quala
- Primary DI
- D023Q90371
- Version / Model
- Q9037
- Catalog Number
- Q9037
- Company Name
- NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Labeler DUNS
- 009831413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-28
- Public Version
- 1
- Public Version Date
- 2022-11-07
- Public Version Status
- New
- Public Device Record Key
- 96383d3f-4265-4412-a8f5-28577eccb29b
Device Description
Quala Scaliva Ejector Screens 25/BG
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
- 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 |
|---|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34859 | Dental suction system | An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D023Q90371 | HIBCC |