FDA UDI
In Commercial Distribution
🇺🇸 United States
Batrik ShoozCovers™
DI: 00690521022928
·
Model: SC-2122-NPDB
·
Batrik Medical Manufacturing Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Batrik ShoozCovers™
- Primary DI
- 00690521022928
- Version / Model
- SC-2122-NPDB
- Catalog Number
- SC-2122-NPDB
- Company Name
- Batrik Medical Manufacturing Inc
- Labeler DUNS
- 243880700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-14
- Public Version
- 1
- Public Version Date
- 2025-02-24
- Public Version Status
- New
- Public Device Record Key
- 79f9552f-dbb5-49ed-8303-5aa8e95fbcc2
Device Description
"ShoozCovers™ Disposable Shoe Covers, X-Large, Marshmallow White, Waterproof Shoe size 12 – 15, ~ 47 cm x 17.5 cm / 18.5” x 6.9”"
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 |
|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15056 | Shoe cover | A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690521022928 | GS1 |
Customer Contacts
- Phone
- 514-631-7988
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from heat and sunlight