FDA UDI
In Commercial Distribution
🇺🇸 United States
Devon
DI: 50192253021552
·
Model: 31159612
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
45
Basic Information
- Brand Name
- Devon
- Primary DI
- 50192253021552
- Version / Model
- 31159612
- Catalog Number
- 31159612
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 45
- Record Status
- Published
- Publish Date
- 2021-07-12
- Public Version
- 1
- Public Version Date
- 2021-07-20
- Public Version Status
- New
- Public Device Record Key
- 3882d2a5-affa-40c8-9f6c-17da1cd75492
Device Description
Devon Magnetic Drape with Stays Neutral Zone 16” x 20” (40.6 cm x 50.8 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZZ | MARKER, SKIN | General, Plastic Surgery | 878.4660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61665 | Surgical instrument containment holder, single-use, non-sterile | A non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10192253021554 | GS1 | ||||
| Primary | 50192253021552 | GS1 |