FDA UDI
Not in Commercial Distribution
🇺🇸 United States
STRADIS
DI: M7528204041
·
Model: 820-404
·
STRADIS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STRADIS
- Primary DI
- M7528204041
- Version / Model
- 820-404
- Company Name
- STRADIS MEDICAL, LLC
- Labeler DUNS
- 174262477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 3
- Public Version Date
- 2022-05-17
- Public Version Status
- Update
- Public Device Record Key
- 02713734-c1af-44a8-a0d5-a04044bf50f1
- Distribution End Date
- 2022-05-16
Device Description
STERILE SEPARATE-GAUZE 4X4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34084 | Wound compression dressing | A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7528204041 | HIBCC |
Customer Contacts
- Phone
- 770-962-2425
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch |