FDA UDI
In Commercial Distribution
🇺🇸 United States
AMD-RITMED SOLON
DI: 10686864048821
·
Model: 54100
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- AMD-RITMED SOLON
- Primary DI
- 10686864048821
- Version / Model
- 54100
- Catalog Number
- 54100
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 1
- Public Version Date
- 2023-07-18
- Public Version Status
- New
- Public Device Record Key
- 7cc4ad33-bd49-4aeb-a125-ae6db411c298
Device Description
AMD-RITMED SOLON - Non-Sterile Wooden Spoons, 3"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILC | Utensil, Eating | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42461 | Tongue depressor, examination, single-use | A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864048828 | GS1 | Outer case | 10 | In Commercial Distribution | |
| Primary | 10686864048821 | GS1 | ||||
| Unit of Use | 00686864048824 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262
- [email protected]
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 80 Percent (%) Relative Humidity