FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Culture Tubes,With Dual Position Cap,Polystyrene, Peel Pack,12 x 75 mm
DI: 00840117334991
·
Model: 42301
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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Basic Information
- Brand Name
- LabChoice Culture Tubes,With Dual Position Cap,Polystyrene, Peel Pack,12 x 75 mm
- Primary DI
- 00840117334991
- Version / Model
- 42301
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- 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
- 10af94a4-740b-484d-9fb7-b6d4950c9448
Device Description
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 | 00810180841115 | GS1 | ||||
| Primary | 00840117334991 | GS1 |