FDA UDI
In Commercial Distribution
🇺🇸 United States
Collimator Cradle 512 asm
DI: 00884838081093
·
Model: 1024280
·
Philips Digital Mammography Sweden AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Collimator Cradle 512 asm
- Primary DI
- 00884838081093
- Version / Model
- 1024280
- Company Name
- Philips Digital Mammography Sweden AB
- Labeler DUNS
- 632899233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2021-08-02
- Public Version Status
- Update
- Public Device Record Key
- e99ed7cb-189b-48be-81d7-5999e33237b5
Device Description
The collimator is intended for a larger compression height range with breasts of larger size.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IZW | Collimator, automatic, radiographic | Radiology | 892.1610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42254 | Fixed-aperture diagnostic x-ray system collimator | A standard, non-motorized, diagnostic x-ray beam-limiting device that has a fixed size opening. It attaches by means of a slot or base plate to a diagnostic x-ray system tube housing and is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas. An aperture diaphragm consists of a sheet of lead with a hole in the middle. The size and shape of the hole determine the size and shape of the x-ray beam exiting from the x-ray system. Cones and cylinders used for beam collimation are made of lead and attach by means of a base plate to an x-ray tube housing assembly. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838081093 | GS1 |