FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NOVO Health Services, LLC
DI: 00810019800641
·
Model: 124674
·
NOVO HEALTH SERVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVO Health Services, LLC
- Primary DI
- 00810019800641
- Version / Model
- 124674
- Catalog Number
- 124674B
- Company Name
- NOVO HEALTH SERVICES, LLC
- Labeler DUNS
- 069936106
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-10
- Public Version
- 2
- Public Version Date
- 2022-10-21
- Public Version Status
- Update
- Public Device Record Key
- e1cc6cba-80e5-473b-a34f-7c96893206b0
- Distribution End Date
- 2022-10-20
Device Description
GreenWrap 36x36", 20-Pk NS
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FRG | Wrap, Sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13735 | Sterilization packaging, single-use | A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019800641 | GS1 |
Customer Contacts
- Phone
- 8138919550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102783 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 10.7 | Pound | |
| Width | 18 | Inch | |
| Height | 4 | Inch |