FDA UDI
In Commercial Distribution
🇺🇸 United States
Sasmar Classic
DI: 09337213008143
·
Model: 50ml
·
Sasmar Pharmaceuticals SPRL
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sasmar Classic
- Primary DI
- 09337213008143
- Version / Model
- 50ml
- Catalog Number
- 880814
- Company Name
- Sasmar Pharmaceuticals SPRL
- Labeler DUNS
- 370696875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1df2f30d-a015-49c2-b7ba-8f42bf2b0848
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33587 | General-body orifice lubricant, non-sterile | A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Obsolete |
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 29337213008147 | GS1 | Shipping Carton | 8 | In Commercial Distribution | |
| Package | 19337213008140 | GS1 | Inner Pack (bundle) | 6 | In Commercial Distribution | |
| Primary | 09337213008143 | GS1 |
Customer Contacts
- Phone
- +3228808220
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131084 | 000 |