FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tyrode's Solution - Acidified
DI: 00893727002996
·
Model: 99252-12X5ML
·
FUJIFILM IRVINE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Tyrode's Solution - Acidified
- Primary DI
- 00893727002996
- Version / Model
- 99252-12X5ML
- Catalog Number
- 99252
- Company Name
- FUJIFILM IRVINE SCIENTIFIC, INC.
- Labeler DUNS
- 057475246
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 6
- Public Version Date
- 2020-08-06
- Public Version Status
- Update
- Public Device Record Key
- 3e540c11-6332-4d45-8379-a0bfdf63186d
- Distribution End Date
- 2020-08-06
Device Description
Tyrode's Solution - Acidified
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
- Yes
- 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 |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 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 | 00893727002996 | GS1 | ||||
| Unit of Use | 10893727002993 | GS1 |
Customer Contacts
- Phone
- 8004375706
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991339 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius