FDA UDI
In Commercial Distribution
🇺🇸 United States
MTI
DI: 10840118416396
·
Model: 7001094-00-228
·
Medical Technology Industries, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MTI
- Primary DI
- 10840118416396
- Version / Model
- 7001094-00-228
- Catalog Number
- 7001094-00-228
- Company Name
- Medical Technology Industries, Inc.
- Labeler DUNS
- 053947946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-30
- Public Version
- 1
- Public Version Date
- 2023-01-09
- Public Version Status
- New
- Public Device Record Key
- 1c2c4d13-9a5d-4af8-87ed-b8b3f1e5a69b
Device Description
Leg Restraint Strap ULTRA-CHIANTI
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FMQ | Restraint, Protective | General Hospital | 880.6760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62482 | Limb/torso/head restraint, reusable | A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10840118416396 | GS1 |
Customer Contacts
- Phone
- 801-887-5114
- [email protected]