FDA UDI
In Commercial Distribution
🇺🇸 United States
MT Protector-Sleeves
DI: 00027479200021
·
Model: PSLEG1
·
MEDI-TECH INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- MT Protector-Sleeves
- Primary DI
- 00027479200021
- Version / Model
- PSLEG1
- Catalog Number
- PSLEG1
- Company Name
- MEDI-TECH INTERNATIONAL CORPORATION
- Labeler DUNS
- 063865158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-07-23
- Public Version
- 2
- Public Version Date
- 2021-09-20
- Public Version Status
- Update
- Public Device Record Key
- 41b6afb7-4f0c-463e-99a2-95518fa256d3
Device Description
MT Protector-Sleeves - Leg Sleeve - Size Universal - White
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13369 | Skin treatment/dressing-supportive limb/finger bandage, single-use | An elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00027479200021 | GS1 | ||||
| Unit of Use | 20274792000218 | GS1 |
Customer Contacts
- Phone
- 414-570-8880
- [email protected]