FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095646376
·
Model: 3012V
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095646376
- Version / Model
- 3012V
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- 352a2f68-ec13-4162-bb62-e83ee5ee6795
Device Description
CryoCLEAR vials, 2.0mL, STERILE, External Threads, Assembled VIOLET Screwcap with Co-Molded Thermoplastic Elastomer (TPE) Sealing Layer, Round Bottom, Self-Standing, Printed Graduations, Writing Space and Barcode, 50/Bag, 10 Bags/Case
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
- 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 |
|---|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64783 | Microbial cryotube IVD | A vial containing porous glass or synthetic polymer beads and/or a liquid cryoprotectant intended to be used for the cryopreservation, storage, and subsequent retrieval of clinical microbial isolates (e.g., bacteria, fungi) for in vitro diagnostic applications. The container enables preservation and storage of the microbial specimens at sub-zero temperatures for extended periods. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840095646390 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 00840095646376 | GS1 | ||||
| Package | 00840095646383 | GS1 | case | 80 | In Commercial Distribution | |
| Unit of Use | 00840095687553 | GS1 |