FDA UDI
In Commercial Distribution
🇺🇸 United States
DryShield
DI: 00850045062088
·
Model: BMD DS-MPS-003
·
Solmetex, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- DryShield
- Primary DI
- 00850045062088
- Version / Model
- BMD DS-MPS-003
- Company Name
- Solmetex, LLC
- Labeler DUNS
- 958831349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- e86e5c72-2733-4b6f-8073-742120a32ba9
Device Description
Mouthpiece - Autoclave - SMALL - 4 Pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 00850045062088 | GS1 | ||||
| Unit of Use | 00850045062033 | GS1 |
Customer Contacts
- Phone
- 1-800-216-5505
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | X-PEDO | ||
| Device Size Text, specify | PEDO | ||
| Device Size Text, specify | MEDIUM | ||
| Device Size Text, specify | LARGE |