FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoTube 3,6 ml SI Internal thread Star foot Round
DI: 15713311000271
·
Model: 379189
·
Nunc A/S
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- CryoTube 3,6 ml SI Internal thread Star foot Round
- Primary DI
- 15713311000271
- Version / Model
- 379189
- Company Name
- Nunc A/S
- Labeler DUNS
- 305971764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 1
- Public Version Date
- 2022-11-28
- Public Version Status
- New
- Public Device Record Key
- fedf131b-e373-4991-84fb-ffb09313ffd0
Device Description
CryoTube 3,6 ml SI Internal thread Star foot Round is used for storage and transportation of biological material for in Vitro Diagnostics.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25713311000278 | GS1 | PACK | 8 | In Commercial Distribution | |
| Primary | 15713311000271 | GS1 | ||||
| Package | 35713311000268 | GS1 | CASE | 4 | In Commercial Distribution | |
| Unit of Use | 85713311000249 | GS1 |