FDA UDI
In Commercial Distribution
🇺🇸 United States
Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900"
DI: 00843356101843
·
Model: GIC190
·
CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900"
- Primary DI
- 00843356101843
- Version / Model
- GIC190
- Company Name
- CYGNUS MEDICAL L.L.C.
- Labeler DUNS
- 103169095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-03-31
- Public Version
- 4
- Public Version Date
- 2022-09-19
- Public Version Status
- Update
- Public Device Record Key
- 3c9fa57d-1dab-43a6-8eb6-f60316e80925
Device Description
Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900" tip to tip, 500 clips per bag (GIC190-5). 2 bags of 500 clips per case (GIC190-10).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64671 | Sterilizer/disinfector rack instrument-holding insert, single-use | A device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a spongy strip through which a portion of the instrument is inserted. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843356101840 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00843356101843 | GS1 | ||||
| Unit of Use | 30843356101844 | GS1 |