FDA UDI
In Commercial Distribution
🇺🇸 United States
NewPort
DI: 10889981085698
·
Model: 91-8496
·
SEASPINE ORTHOPEDICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NewPort
- Primary DI
- 10889981085698
- Version / Model
- 91-8496
- Catalog Number
- 91-8496
- Company Name
- SEASPINE ORTHOPEDICS CORPORATION
- Labeler DUNS
- 079840876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-31
- Public Version
- 4
- Public Version Date
- 2019-05-07
- Public Version Status
- Update
- Public Device Record Key
- 0c07f68e-e602-4acc-a867-5f2b2746079d
Device Description
Screw Sizing Block
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 |
|---|---|---|---|---|
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44796 | Medical ruler, reusable | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981085698 | GS1 |
Customer Contacts
- Phone
- +1(866)942-8698
- [email protected]