Leakbuster
- Primary DI
- 00840165500362
- Company
- Starplex Scientific Corp.
- Model
- B1202-1W-OR
- Device description
- Specimen Container, 120 ml, White Cap, Individually Packaged in Peel Pack, Sterile.
- Published
- 2025-05-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 859771235
- Device count
- 100
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840165500379 | Primary | GS1 | 0 | |
| 00840165500362 | Unit of Use | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00840165500379 | Primary | GS1 | 0 | | | | |
| 00840165500362 | Unit of Use | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| FMH | Container, Specimen, Sterile | 1 | Pathology | 864.3250 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
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