FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline-Microtek
DI: 10748426141125
·
Model: Protective Restraints
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Medline-Microtek
- Primary DI
- 10748426141125
- Version / Model
- Protective Restraints
- Catalog Number
- PSKB100N
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-04-08
- Public Version
- 1
- Public Version Date
- 2025-04-16
- Public Version Status
- New
- Public Device Record Key
- 77cf4491-7f76-4239-bf8f-a3867a7195e2
Device Description
KNEE AND BODY STRAP, DISPOSABLE, NONWOVEN, TWO PIECE, 4" X 60"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| FMQ | Restraint, Protective | General Hospital | 880.6760 | 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 | 00748426141128 | GS1 | ||||
| Primary | 10748426141125 | GS1 |