FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DISPETTE®
DI: 07612964013656
·
Model: FH1705
·
Guest Scientific AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DISPETTE®
- Primary DI
- 07612964013656
- Version / Model
- FH1705
- Catalog Number
- FH1705
- Company Name
- Guest Scientific AG
- Labeler DUNS
- 483342734
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-07
- Public Version
- 2
- Public Version Date
- 2021-10-20
- Public Version Status
- Update
- Public Device Record Key
- 77a77e5c-be9c-43da-8c96-774c89863c8e
- Distribution End Date
- 2021-06-30
Device Description
DISPETTE LEVELING STAND
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JPH | Test, Erythrocyte Sedimentation Rate | Hematology | 864.6700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15186 | Test tube rack | A non-sterile device designed to hold test tubes in an upright and secured position. It is typically made of metal and/or plastic and consists of a base plate upon which it stands and second plate containing a mesh (grid of square slots) or round holes which is supported at a given height with spacers or diving walls. It is typically used in a clinical laboratory. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07612964013656 | GS1 | ||||
| Package | 07612964013649 | GS1 | BULK PACKAGING | 20 | Not in Commercial Distribution | 2021-06-30 |
| Package | 07612964013625 | GS1 | INDIVIDUAL PACKAGING | 1 | Not in Commercial Distribution | 2021-06-30 |