FDA UDI
In Commercial Distribution
🇺🇸 United States
CYGNUS
DI: 00843356102734
·
Model: TRL1218
·
CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- CYGNUS
- Primary DI
- 00843356102734
- Version / Model
- TRL1218
- Company Name
- CYGNUS MEDICAL L.L.C.
- Labeler DUNS
- 103169095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 1
- Public Version Date
- 2024-03-04
- Public Version Status
- New
- Public Device Record Key
- db0ba3cf-a09e-40f4-a16f-ac7f5f0f9ae2
Device Description
12"x18" Tray Liner 50 parts per bag
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 |
|---|---|---|---|---|
| LRP | Tray, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64367 | Instrument tray cover, single-use | A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843356102731 | GS1 | CASE | 800 | In Commercial Distribution | |
| Primary | 00843356102734 | GS1 | ||||
| Unit of Use | 30843356102735 | GS1 |