FDA UDI
In Commercial Distribution
🇺🇸 United States
Sperm Select System
DI: 60888937003613
·
Model: SM600
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sperm Select System
- Primary DI
- 60888937003613
- Version / Model
- SM600
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 5
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 391e261b-f2c0-4e85-9456-1aa986508a21
Device Description
Contents: One syringe of Sperm Select non-pyrogenic sterile membrane filtered, one vial of Medium non-pyrogenic sterile membrane filtered, one syringe carrier, two 3ml syringe, two 20-G needle, one 21-g needle, one vial holder, one syringe plug and one name tag
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HDR | Cap, Cervical | Obstetrics/Gynecology | 884.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59858 | Spermatozoa/semen motility medium supplement | A sterile supplemental solution intended to be added to the medium during semen preparation for use in assisted reproduction technique (ART) procedures so as to enhance semen fluidity and sperm motility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60888937003613 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K900308 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at 2-8 degrees C/36-47 degrees F. Protect from freezing.