FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD-RITMED SOLON
DI: 10686864049170
·
Model: 58000
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AMD-RITMED SOLON
- Primary DI
- 10686864049170
- Version / Model
- 58000
- Catalog Number
- 58000
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-16
- Public Version
- 2
- Public Version Date
- 2023-05-31
- Public Version Status
- Update
- Public Device Record Key
- 90a5aac9-26f2-41e2-8980-11c369a77649
- Distribution End Date
- 2023-05-30
Device Description
AMD-RITMED SOLON INFANT TONGUE DEPRESSORS
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMA | DEPRESSOR, TONGUE, NON-SURGICAL | General Hospital | 880.6230 | 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 | 12686864049178 | GS1 | Pack | 100 | Not in Commercial Distribution | 2023-05-30 |
| Primary | 10686864049170 | GS1 | ||||
| Package | 20686864049177 | GS1 | Outer Case | 10 | Not in Commercial Distribution | 2023-05-30 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature