FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Culture Tubes,With Dual Position Cap,Polystyrene,W/Graduated Marking
DI: 00840117337190
·
Model: 42304
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- LabChoice Culture Tubes,With Dual Position Cap,Polystyrene,W/Graduated Marking
- Primary DI
- 00840117337190
- Version / Model
- 42304
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-02-03
- Public Version
- 1
- Public Version Date
- 2025-02-11
- Public Version Status
- New
- Public Device Record Key
- 62cd4664-3a77-49a4-914c-b92b0f9c7191
Device Description
12 x 75 mm, STERILE-R
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
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KJG | Tube, Tissue Culture | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14189 | Culture tube | A sterile glass or plastic tube-like container used to hold a culture specimen. 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 | 00810180841108 | GS1 | ||||
| Primary | 00840117337190 | GS1 | ||||
| Package | 00840117335028 | GS1 | Case | 40 | In Commercial Distribution |