FDA UDI
In Commercial Distribution
🇺🇸 United States
ASTEC
DI: B951AI4030YL1
·
Model: ICSI Injection Pipette
·
ASTEC BIO USA INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- ASTEC
- Primary DI
- B951AI4030YL1
- Version / Model
- ICSI Injection Pipette
- Catalog Number
- AI4030-YL
- Company Name
- ASTEC BIO USA INC
- Labeler DUNS
- 041434170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-09-19
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 88334ecb-ee0e-477d-bad2-932ff64543fd
Device Description
5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked
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
- Yes
- 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 |
|---|---|---|---|---|
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46553 | Assisted reproduction microtool | A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. 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 | B951AI4030YL0 | HIBCC | ||||
| Primary | B951AI4030YL1 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 25 Degrees Celsius