FDA UDI
In Commercial Distribution
🇺🇸 United States
SpandaNette
DI: 00027479136252
·
Model: MTSN13625
·
MEDI-TECH INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpandaNette
- Primary DI
- 00027479136252
- Version / Model
- MTSN13625
- Catalog Number
- MTSN13625
- Company Name
- MEDI-TECH INTERNATIONAL CORPORATION
- Labeler DUNS
- 063865158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-29
- Public Version
- 2
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- b8cad8c5-9b55-4c9c-b3e9-76380c9adfff
Device Description
SpandaNette Tubular Cotton Stockinette Single Ply - Natural - Size 6 - Non-Sterile
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 |
|---|---|---|---|---|
| 35374 | Stockinette | A knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00027479136252 | GS1 |
Customer Contacts
- Phone
- 414-570-8880
- [email protected]