FDA UDI
In Commercial Distribution
🇺🇸 United States
MICTEC MAGNET NEEDLE CATCHER
DI: 00192896007994
·
Model: 20918-80
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICTEC MAGNET NEEDLE CATCHER
- Primary DI
- 00192896007994
- Version / Model
- 20918-80
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 1
- Public Version Date
- 2018-09-24
- Public Version Status
- New
- Public Device Record Key
- 8ee20a3f-bb34-4672-b85f-62e342d27b87
Device Description
MICTEC MAGNET NEEDLE CATCHER
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62044 | Sharp surgical instrument retrieval magnet | A non-sterile, magnetic device intended to be used primarily within an operating room (OR) to pick up metallic instruments/devices (e.g., needles, blades) that have been dropped/mislaid on the floor. It is a non-powered device that includes a fixed magnetic rod/axle with wheels connected to long handle, whereby small, typically sharp, metallic instruments are picked up by magnetism. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B09920918800 | HIBCC | ||||
| Primary | 00192896007994 | GS1 |
Customer Contacts
- Phone
- 8008217496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5.0mm Diameter | ||
| Length | 300 | Millimeter |