FDA UDI
In Commercial Distribution
🇺🇸 United States
Anchor Tips, 300uL
DI: 09120123910022
·
Model: 300uL
·
STRATEC Consumables GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Anchor Tips, 300uL
- Primary DI
- 09120123910022
- Version / Model
- 300uL
- Catalog Number
- 10036506
- Company Name
- STRATEC Consumables GmbH
- Labeler DUNS
- 300477696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-14
- Public Version
- 1
- Public Version Date
- 2026-01-22
- Public Version Status
- New
- Public Device Record Key
- f7b235ee-b7be-4d8b-9c6a-f2fc553ed748
Device Description
Vessels used to transport sample from the laboratory container to the cuvette with an automated pipetting system in the KleeYa Evaluation Unit single use 960 pcs
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
- No
- 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 |
|---|---|---|---|---|
| 56701 | Chemiluminescent immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09120123910015 | GS1 | 5760 | In Commercial Distribution | ||
| Primary | 09120123910022 | GS1 |