FDA UDI
In Commercial Distribution
🇺🇸 United States
Novo Surgical Inc.
DI: 00842331149702
·
Model: OP7141-33
·
NOVO SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novo Surgical Inc.
- Primary DI
- 00842331149702
- Version / Model
- OP7141-33
- Catalog Number
- OP7141-33
- Company Name
- NOVO SURGICAL, INC.
- Labeler DUNS
- 033029433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-12
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 26a42e7a-724d-4623-965a-458a35e160fc
Device Description
flieringa fixation ring, 22.0 mm diameter
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11950 | Percussion hammer, manual, reusable | A hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842331149702 | GS1 |
Customer Contacts
- Phone
- 1877-860-6686
- [email protected]