FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095636728
·
Model: 6285Y
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095636728
- Version / Model
- 6285Y
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- 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
- 183b54b9-0e61-438f-a302-8bf641d47fc9
Device Description
Centrifuge Tube, 15mL, Attached Yellow Flat Top Screw Cap, PP, Printed Graduations, STERILE, 25/Bag, 20 Bags/Unit
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 |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43761 | Centrifuge tube IVD | A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. 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 | 00840095687669 | GS1 | ||||
| Primary | 00840095636728 | GS1 |