FDA UDI
In Commercial Distribution
🇺🇸 United States
Lateral Retractor
DI: 10889981099367
·
Model: 95-6892
·
SEASPINE ORTHOPEDICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lateral Retractor
- Primary DI
- 10889981099367
- Version / Model
- 95-6892
- Catalog Number
- 95-6892
- Company Name
- SEASPINE ORTHOPEDICS CORPORATION
- Labeler DUNS
- 079840876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a649cc07-a04f-40be-8242-97d62d44a991
Device Description
Anterior Left Blade, 90mm
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 |
|---|---|---|---|---|
| 35315 | Orthopaedic retractor | A hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981099367 | GS1 |
Customer Contacts
- Phone
- +1(760)727-8399
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 90mm |