FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10888551034814
·
Model: STJ11161M
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10888551034814
- Version / Model
- STJ11161M
- Catalog Number
- STJ11161M
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 8
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 8e8c8fbd-e4cb-4cd7-b1c5-bbcc8fdf053e
- Distribution End Date
- 2019-04-17
Device Description
FEMORAL COMPRESSION SYSTEM MODIFIED -- PUMP AND GAUGE NOT INCLUDED --
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NMF | Clamp, vascular, reprocessed | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47927 | Femoral artery compression system, manual, single-use | A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888551034814 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120204 | 000 |