FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica IM cPSA PRE
DI: 00630414598703
·
Model: 10995546
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atellica IM cPSA PRE
- Primary DI
- 00630414598703
- Version / Model
- 10995546
- Catalog Number
- 10995546
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-14
- Public Version
- 6
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- d4384a41-8d06-483f-b3be-172f6ac53e2b
Device Description
Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NAF | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54677 | Complexed prostate specific antigen (cPSA) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414598703 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990055 | 001 |
| P990055 | 002 |
| P990055 | 004 |
| P990055 | 006 |
| P990055 | 007 |
| P990055 | 008 |
| P990055 | 009 |
| P990055 | 010 |
| P990055 | 012 |
| P990055 | 016 |
| P990055 | 017 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius