FDA UDI
In Commercial Distribution
🇺🇸 United States
XRpad Digital X-Ray Detector System
DI: 00812589020122
·
Model: XRpad LBP
·
PerkinElmer Technologies GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XRpad Digital X-Ray Detector System
- Primary DI
- 00812589020122
- Version / Model
- XRpad LBP
- Catalog Number
- 95510920H-01
- Company Name
- PerkinElmer Technologies GmbH & Co. KG
- Labeler DUNS
- 315030809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-29
- Public Version
- 3
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- bd9f83cf-d394-47ca-baf2-259820934ce6
Device Description
Rechargeable Lithium-Ion Battery for use with PerkinElmer XRpad Detectors and Chargers Only
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60265 | Flat panel x-ray detector integration unit | A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812589020122 | GS1 |
Customer Contacts
- Phone
- +496123971300
- [email protected]
- Phone
- (844) 726-8228
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.4 | Kilogram | |
| Width | 211.2 | Millimeter | |
| Length | 238.5 | Millimeter | |
| Height | 6.3 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- May cause risk of fire, explosion, or a severe burn hazard
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from children
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not crush or expose to fire or incinerate
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 35 – 85 Percent (%) Relative Humidity