FDA UDI
In Commercial Distribution
🇺🇸 United States
Inoculating Loop 10ul Typenex
DI: 06973267012175
·
Model: 10ul,flexible, blue, LP0203
·
ZHEJIANG RUNLAB TECHNOLOGY CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Inoculating Loop 10ul Typenex
- Primary DI
- 06973267012175
- Version / Model
- 10ul,flexible, blue, LP0203
- Company Name
- ZHEJIANG RUNLAB TECHNOLOGY CO., LTD
- Labeler DUNS
- 529124298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-10
- Public Version
- 1
- Public Version Date
- 2023-10-18
- Public Version Status
- New
- Public Device Record Key
- eec2389a-cd02-4c01-952b-51c416518939
Device Description
10ul,flexible, blue, LP0203
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 866.2660 | 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 | 06973267012151 | GS1 | inner bag | 20 | In Commercial Distribution | |
| Primary | 06973267012175 | GS1 | ||||
| Package | 06973267012137 | GS1 | inner box | 50 | In Commercial Distribution | |
| Package | 16973267012134 | GS1 | case | 6 | In Commercial Distribution |