FDA UDI
In Commercial Distribution
🇺🇸 United States
Streamway Filter
DI: 10862675000313
·
Model: STM 2015
·
SKYLINE MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Streamway Filter
- Primary DI
- 10862675000313
- Version / Model
- STM 2015
- Catalog Number
- STM 2015
- Company Name
- SKYLINE MEDICAL INC.
- Labeler DUNS
- 024774680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3eeafd93-05e0-4a08-a8d9-5d6bdcef5bbd
Device Description
Procedure Filter for Streamway device
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62064 | Suction system filter, tissue, non-sterile | A non-sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic purposes (e.g., histological analysis). It consists of a meshed piece of textile material (e.g., nylon). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10862675000313 | GS1 |
Customer Contacts
- Phone
- 651-389-4800
- [email protected]