FDA UDI
In Commercial Distribution
🇺🇸 United States
Tensoplast
DI: 04042809019308
·
Model: 72050-57
·
BSN MEDICAL (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- Tensoplast
- Primary DI
- 04042809019308
- Version / Model
- 72050-57
- Catalog Number
- 72050-57
- Company Name
- BSN MEDICAL (PTY) LTD
- Labeler DUNS
- 636017233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 4f323604-c5cb-4390-a654-0f5b76aef926
Device Description
TENSOPLAST 5CM X 1.5M 6 BLOWN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61223 | Pressure bandage, non-latex, reusable | A strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04042809019322 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 04042809019308 | GS1 | ||||
| Unit of Use | 04042809402940 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 5 | Centimeter | |
| Length | 150 | Centimeter |