FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Boot Cover
DI: 08936064200167
·
Model: MDC-PS13
·
TNG INVESTMENT AND TRADING JOINT STOCK COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Boot Cover
- Primary DI
- 08936064200167
- Version / Model
- MDC-PS13
- Company Name
- TNG INVESTMENT AND TRADING JOINT STOCK COMPANY
- Labeler DUNS
- 555325484
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 1
- Public Version Date
- 2020-08-21
- Public Version Status
- New
- Public Device Record Key
- 91b04b31-eb00-4a88-af39-ec7e656155c7
Device Description
Non-woven fabric Disposable, lightweight, comfortable to wear, shoe protection
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BWP | Shoe And Shoe Cover, Conductive | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61937 | Shoe cover, non-conductive, sterile | A sterile device made of a non-conductive, non-woven synthetic fabric materials intended to be worn over the shoes of healthcare staff typically during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08936064200167 | GS1 |