FDA UDI
In Commercial Distribution
🇺🇸 United States
INSIGHT Pediatric Film
DI: 40889978064652
·
Model: INSIGHT Pediatric Film
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- INSIGHT Pediatric Film
- Primary DI
- 40889978064652
- Version / Model
- INSIGHT Pediatric Film
- Catalog Number
- 8064651
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 61d30e9a-378d-4dad-9ef4-b789c2fd4624
Device Description
INSIGHT Pediatric Film 35X43cm 100SH
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IWZ | Film, radiographic | Radiology | 892.1840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40979 | Medical x-ray film, screen | A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60889978064656 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 40889978064652 | GS1 | ||||
| Unit of Use | 00889978064654 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- Low: 30 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- Low: 60 Percent (%) Relative Humidity