FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ-Squeeze
DI: 05060170181676
·
Model: 290 micron tip id
·
RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- EZ-Squeeze
- Primary DI
- 05060170181676
- Version / Model
- 290 micron tip id
- Catalog Number
- 7-72-3290/20
- Company Name
- RESEARCH INSTRUMENTS LIMITED
- Labeler DUNS
- 536139413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 513216ad-1a17-4876-8c2f-53f17b724f32
Device Description
Assisted Reproduction Microtools (Pipettes)
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05060170181676 | GS1 | ||||
| Unit of Use | 05060170186084 | GS1 |
Customer Contacts
- Phone
- 4546790202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991261 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 290 | Micrometer |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight (UV)