FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Defend
DI: 00843471131725
·
Model: SW-3000
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Defend
- Primary DI
- 00843471131725
- Version / Model
- SW-3000
- Catalog Number
- SW-3000
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-30
- Public Version
- 2
- Public Version Date
- 2023-10-13
- Public Version Status
- Update
- Public Device Record Key
- 07daf670-84e4-47d3-bbef-935654fe74f8
- Distribution End Date
- 2023-10-12
Device Description
Disposable Sterilization Wrap (CSR) 30 Inch x 30 Inch
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
- 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
- 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 |
|---|---|---|---|---|
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60908 | Sterilization container liner | A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843471131722 | GS1 | Box | 250 | Not in Commercial Distribution | 2023-10-12 |
| Primary | 00843471131725 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]