FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Disposable Troop Elevation Pillow
DI: 10856446007007
·
Model: 10-910-00
·
CR ENTERPRISES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Disposable Troop Elevation Pillow
- Primary DI
- 10856446007007
- Version / Model
- 10-910-00
- Catalog Number
- 10-910-00
- Company Name
- CR ENTERPRISES, LLC
- Labeler DUNS
- 006375677
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-04-14
- Public Version
- 2
- Public Version Date
- 2021-09-15
- Public Version Status
- Update
- Public Device Record Key
- 15b098d1-ff29-427c-9ba5-0814ccb9aa85
- Distribution End Date
- 2021-01-01
Device Description
Disposable barrier covered Troop Elevation Pillow - 4 per box
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62292 | Freestanding patient positioner, single-use | A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00856446007000 | GS1 | ||||
| Primary | 10856446007007 | GS1 |
Customer Contacts
- Phone
- 972-625-5177
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Inch | |
| Width | 20 | Inch | |
| Height | 5.75 | Inch |