FDA UDI
In Commercial Distribution
🇺🇸 United States
Burnshield
DI: 06007645007917
·
Model: 881010
·
BURNSHIELD (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Burnshield
- Primary DI
- 06007645007917
- Version / Model
- 881010
- Catalog Number
- 881010
- Company Name
- BURNSHIELD (PTY) LTD
- Labeler DUNS
- 635842958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-01
- Public Version
- 3
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 2ec03b41-1b78-4ef4-bfa8-c1ae5fa9d2c2
Device Description
BURNSHIELD BLANK WOOL 1.6x1.8m(64X71")
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47695 | Cotton burn sheet | A covering designed to treat large to massive patient burns made of woven cotton impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes [e.g., towel to blanket (sheet)] and may also be used to smother small flames. It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06007645007917 | GS1 |
Customer Contacts
- Phone
- +27114405171
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943728 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6600 | Gram | |
| Width | 1600 | Millimeter | |
| Length | 1800 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius