FDA UDI
In Commercial Distribution
🇺🇸 United States
PICSI®
DI: 20888937025860
·
Model: BCT-PICSI-20-US
·
Coopersurgical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- PICSI®
- Primary DI
- 20888937025860
- Version / Model
- BCT-PICSI-20-US
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-10-20
- Public Version
- 1
- Public Version Date
- 2025-10-28
- Public Version Status
- New
- Public Device Record Key
- 53676a5e-bea5-4500-a2b4-34855e3d92fa
Device Description
PICSI® Sperm Selection Device
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 |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58052 | Hyaluronan binding sperm selection device | A device intended to be used for the in vitro selection of mature (hyaluronan-binding) sperm to treat infertile couples by intracytoplasmic sperm injection (ICSI). It typically consists of a plastic culture dish with microdots of hyaluronan hydrogel attached to the interior bottom. The head of a mature sperm carries a hyaluronan-specific receptor that enables it to bind to hyaluronan, the main component of the cumulus oophorus layer that surrounds the oocyte. The device provides a means to select mature sperm, which exhibit high DNA integrity, by mimicking their natural binding to the cumulus oophorus. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10888937025863 | GS1 | ||||
| Primary | 20888937025860 | GS1 |