FDA UDI
In Commercial Distribution
🇺🇸 United States
Stradis Medical, LLC.
DI: M75220100SSOP0
·
Model: 20100SSOP
·
STRADIS MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Stradis Medical, LLC.
- Primary DI
- M75220100SSOP0
- Version / Model
- 20100SSOP
- Company Name
- STRADIS MEDICAL LLC
- Labeler DUNS
- 043537671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 1
- Public Version Date
- 2020-06-15
- Public Version Status
- New
- Public Device Record Key
- 1e7ef553-32b5-4a11-af0d-1373b6c74935
Device Description
STANDARD OPERATIVE PACK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PXC | Personal Protection Kit | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61938 | Surgical/examination garment kit | A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M75220100SSOP0 | HIBCC | ||||
| Package | M75220100SSOP5 | HIBCC | OUTER BOX | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-424-8520
- [email protected]