FDA UDI
In Commercial Distribution
🇺🇸 United States
Cygnus
DI: 20814707024689
·
Model: GTG-A-2000
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
Basic Information
- Brand Name
- Cygnus
- Primary DI
- 20814707024689
- Version / Model
- GTG-A-2000
- Catalog Number
- GTG-A-2000
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- 6450f7f2-12f3-4a61-a067-d723f910d038
Device Description
GATOR INSTRUMENT TIP GUARD™, WITH RADIOPAQUE THREAD USED TO PROTECT DELICATE SCISSORS &PREVENT PEEL POUCH PUNTURES. PACKAGED-4 BAGS OF 500 EACH
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 65161 | Instrument tray, single-use | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure. It is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00814707024685 | GS1 | ||||
| Primary | 20814707024689 | GS1 |