FDA UDI
In Commercial Distribution
🇺🇸 United States
Sputum Dipper
DI: 28053326005019
·
Model: 2U063S01
·
COPAN ITALIA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Sputum Dipper
- Primary DI
- 28053326005019
- Version / Model
- 2U063S01
- Catalog Number
- 2U063S01
- Company Name
- COPAN ITALIA SPA
- Labeler DUNS
- 428981112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-01-17
- Public Version
- 1
- Public Version Date
- 2024-01-25
- Public Version Status
- New
- Public Device Record Key
- 361b9453-3d39-4ab8-9a59-b598b5bfac3f
Device Description
Transfer device sterile individually wrapped for SL solution
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64876 | Specimen transfer scooping tool IVD | A hand-held manual instrument intended to be used to scoop a clinical specimen or microbial isolate for transfer from a primary vessel to a secondary container (e.g., from a specimen collection receptacle to a reagent tube, or from a culture medium to a general laboratory test tube) for subsequent in vitro diagnostic analysis and/or other investigation. It is typically a slender device with a loop, rake, or ball at the distal end used to scoop and transfer the clinical specimen or microbial isolate. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38053326005016 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 28053326005019 | GS1 | ||||
| Unit of Use | 18053326005012 | GS1 |