FDA UDI
In Commercial Distribution
🇺🇸 United States
SURESTREAM
DI: 10886704072553
·
Model: 70020US
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SURESTREAM
- Primary DI
- 10886704072553
- Version / Model
- 70020US
- Catalog Number
- 70020US
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 4
- Public Version Date
- 2022-01-28
- Public Version Status
- Update
- Public Device Record Key
- 9e3d3a23-dda1-46b8-841b-a7c16ec6132f
- Distribution End Date
- 2024-12-31
Device Description
Intraspinal Catheter Kit A.1 SureStream Catheter;19-gauge;with Guide Wire B.1 Catheter-threading guide C.1 SureStream Connector;titanium D. Anchors 1 each of 4 styles
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
- 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 |
|---|---|---|---|---|
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61493 | Spinal port/catheter | A sterile implantable device intended to provide access to the subarachnoid (intrathecal) space of the spinal column for infusion (e.g., chemotherapeutic agents, pain relieving drugs) and/or drainage [e.g., cerebrospinal fluid (CSF)]. It consists of a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle, attached to a distal catheter which passes into the target site. It is made of metal [e.g., titanium (Ti)] and synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704072553 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890055 | 005 |
| P890055 | 008 |
| P890055 | 011 |
| P890055 | 012 |
| P890055 | 015 |
| P890055 | 016 |
| P890055 | 017 |
| P890055 | 018 |
| P890055 | 021 |
| P890055 | 023 |
| P890055 | 024 |
| P890055 | 027 |
| P890055 | 038 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if opened or damaged.