FDA UDI
In Commercial Distribution
🇺🇸 United States
NovoSort
DI: B686100SB01SRS0300000
·
Model: 1
·
Reproductive Solutions
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NovoSort
- Primary DI
- B686100SB01SRS0300000
- Version / Model
- 1
- Catalog Number
- 100SB01SRS030000
- Company Name
- Reproductive Solutions
- Labeler DUNS
- 118022050
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- 1b282046-4e51-43c5-baa0-ca6e2763f7b5
Device Description
A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. The Novo is a component designed to facilitate isolation of sperm while in the ProteX.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUD | Labware, Assisted Reproduction, Exempt | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63772 | Semen specimen collection container | A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B686100SB01SRS0300000 | HIBCC |
Customer Contacts
- Phone
- 8004650368
- [email protected]