FDA UDI
In Commercial Distribution
🇺🇸 United States
Novaplus®
DI: 20809160022204
·
Model: V3230
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Novaplus®
- Primary DI
- 20809160022204
- Version / Model
- V3230
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 3
- Public Version Date
- 2019-11-27
- Public Version Status
- Update
- Public Device Record Key
- ab9dd769-1546-4cd2-9e46-cae21c0fe4c9
Device Description
Bag: Sponge Ct 10.25X32 2.0ml Blu 250/cs
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LWH | Counter, sponge, surgical | General Hospital | 880.2740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13693 | Surgical sponge-counting rack | A device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30809160022201 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 20809160022204 | GS1 | ||||
| Unit of Use | 10809160022207 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature