FDA UDI
In Commercial Distribution
🇺🇸 United States
Novo Surgical
DI: G5869133040
·
Model: 9133-04
·
NOVO SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novo Surgical
- Primary DI
- G5869133040
- Version / Model
- 9133-04
- Catalog Number
- 9133-04
- Company Name
- NOVO SURGICAL, INC.
- Labeler DUNS
- 033029433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- a3346d83-39f6-49c4-8e1e-9e166cf0b14b
Device Description
osteotome caps, gas or steam permeable, latex-free, 50 per package, diameter: 3/4", length: 1", blue-tint w/ vents
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G5869133040 | HIBCC |
Customer Contacts
- Phone
- +1(877)860-6686
- [email protected]