FDA UDI
In Commercial Distribution
🇺🇸 United States
OSMETTE III 10 ul Pipet Piston 2/pk
DI: 00850041049366
·
Model: 2036
·
Precision Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSMETTE III 10 ul Pipet Piston 2/pk
- Primary DI
- 00850041049366
- Version / Model
- 2036
- Catalog Number
- 2036
- Company Name
- Precision Systems, Inc.
- Labeler DUNS
- 001001676
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-14
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- b4f1c517-1fb2-404c-80f6-38be3b3a2d86
Device Description
OSMETTE III 10 ul Pipet Piston 2/pk
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJM | Osmometer For Clinical Use | Clinical Chemistry | 862.2730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52884 | Osmolality IVD, kit, freezing point | A collection of reagents and other associated materials intended to be used for the quantitative measurement of osmolality of a clinical specimen, using a freezing point method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850041049366 | GS1 |
Customer Contacts
- Phone
- 508-655-7010
- [email protected]