FDA UDI
In Commercial Distribution
🇺🇸 United States
RI MSC
DI: 05060170180181
·
Model: Migration Sedimenation Chamber
·
RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- RI MSC
- Primary DI
- 05060170180181
- Version / Model
- Migration Sedimenation Chamber
- Catalog Number
- 7-74-501/20
- Company Name
- RESEARCH INSTRUMENTS LIMITED
- Labeler DUNS
- 536139413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- fde3c935-018b-49aa-809a-ce40b4daf864
Device Description
Assisted Reproduction Labware
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQK | LABWARE, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17987 | Sperm filtration system | An assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060170180181 | GS1 | ||||
| Unit of Use | 05060170183434 | GS1 |
Customer Contacts
- Phone
- 4546790202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112413 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight (UV)
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius