FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Summit X-ray Collimator
DI: B307D8000
·
Model: D800
·
SUMMIT INDUSTRIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Summit X-ray Collimator
- Primary DI
- B307D8000
- Version / Model
- D800
- Catalog Number
- D800
- Company Name
- SUMMIT INDUSTRIES, LLC
- Labeler DUNS
- 130235187
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2021-04-29
- Public Version Status
- Update
- Public Device Record Key
- 2906f387-ea67-470f-bc94-f374290310dc
- Distribution End Date
- 2018-09-13
Device Description
Collimator, manual, Radiographic (892-1610)
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 |
|---|---|---|---|---|
| IZX | Collimator, manual, radiographic | Radiology | 892.1610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42253 | Manual-aperture-control diagnostic x-ray system collimator, non-motorized | A standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B307D8000 | HIBCC |
Customer Contacts
- Phone
- +17733534000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K874687 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 10 – 40 Degrees Celsius