FDA UDI
In Commercial Distribution
🇺🇸 United States
STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20
DI: 03661532000349
·
Model: 1
·
CRYO BIO SYSTEM
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20
- Primary DI
- 03661532000349
- Version / Model
- 1
- Catalog Number
- 016584
- Company Name
- CRYO BIO SYSTEM
- Labeler DUNS
- 500731872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-03
- Public Version
- 1
- Public Version Date
- 2020-11-11
- Public Version Status
- New
- Public Device Record Key
- 4cbea75c-b4e8-4665-89c6-d91e11c5f190
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48008 | Tissue cryostorage straw vitrification set | A collection of sterile devices designed for use in the vitrification process and cryopreservation of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It typically consists of a tissue storage straw, a curved spatula or capillary tube (used for the capture of the specimen) which may be colour-coded, and an insertion device for positioning of the spatula or capillary tube with the specimen into the tissue collection straw. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661532000349 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002595 | 000 |