FDA UDI
In Commercial Distribution
🇺🇸 United States
Oasis PLUS Biodegradable Scope Transport Tray with reversible lid
DI: 00843356100761
·
Model: OP1330
·
CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Oasis PLUS Biodegradable Scope Transport Tray with reversible lid
- Primary DI
- 00843356100761
- Version / Model
- OP1330
- Company Name
- CYGNUS MEDICAL L.L.C.
- Labeler DUNS
- 103169095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 7e7f545c-4214-43e0-89e3-987f7759325e
Device Description
Oasis PLUS Biodegradable Scope Transport Tray with reversible lid - 30 Lids
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 |
|---|---|---|---|---|
| PXV | General Purpose Instrument Tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47081 | Endoscope transport trolley tray | A support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 30843356100762 | GS1 | ||||
| Primary | 00843356100761 | GS1 |