FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mach-SLO™
DI: 10810000524102
·
Model: S430S
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Mach-SLO™
- Primary DI
- 10810000524102
- Version / Model
- S430S
- Catalog Number
- S430S
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2019-08-16
- Public Version
- 3
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 13ac85b0-ab9c-47f0-b074-97e28c527586
- Distribution End Date
- 2020-12-31
Device Description
Mach-SLO™ Die Silicone Material
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the 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 | 10810000524102 | GS1 | ||||
| Unit of Use | 00810000524105 | GS1 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat, light, or moisture