FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NOVO Health Services, LLC
DI: 00812564032201
·
Model: 121248
·
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
- 00812564032201
- Version / Model
- 121248
- Catalog Number
- 121248
- 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
- 2018-10-05
- Public Version
- 3
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 91e85d4e-c365-4122-abb6-43e710432e36
- Distribution End Date
- 2020-06-02
Device Description
2 GOWN BASIC PACK
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44058 | General surgical procedure kit, non-medicated, reusable | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812564032201 | GS1 |
Customer Contacts
- Phone
- 8138919550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090383 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7 | Inch | |
| Width | 12 | Inch | |
| Weight | 5.7 | Pound |