FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROTOOLS (Assisted Hatching Pipette)
DI: 07540268000815
·
Model: AH-3001
·
Arsci Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- MICROTOOLS (Assisted Hatching Pipette)
- Primary DI
- 07540268000815
- Version / Model
- AH-3001
- Company Name
- Arsci Inc.
- Labeler DUNS
- 241975256
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-10-07
- Public Version
- 1
- Public Version Date
- 2022-10-17
- Public Version Status
- New
- Public Device Record Key
- 06ffd10f-6c4c-47bf-a02b-dc9772dd47ce
Device Description
A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Assisted Hatching Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to puncture a hole in the zona pellucida to enable embryo assisted hatching using Tyrode’s acid solution. Intended for one-time use.
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 |
|---|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | 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 | 07540268000020 | GS1 | ||||
| Primary | 07540268000815 | GS1 |
Customer Contacts
- Phone
- 450-674-6886
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102480 | 000 |