FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count
DI: 60840161307134
·
Model: 50Z989MD10/16
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count
- Primary DI
- 60840161307134
- Version / Model
- 50Z989MD10/16
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 2
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- 41c8bdd7-4b30-42ab-a109-4d89a296ffd6
- Distribution End Date
- 2026-04-08
Device Description
Mr. Thirsty® One-Step - High Volume Evacuator - Medium (with 10mm and 16mm Adaptors) - 50 Count
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 60840161307134 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 136 | Millimeter | |
| Width | 54 | Millimeter | |
| Height | 57 | Millimeter |