FDA UDI
In Commercial Distribution
🇺🇸 United States
VARIANT
DI: B030SPO1151180
·
Model: SPO-115-118
·
CAMBER SPINE TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VARIANT
- Primary DI
- B030SPO1151180
- Version / Model
- SPO-115-118
- Company Name
- CAMBER SPINE TECHNOLOGIES, LLC
- Labeler DUNS
- 054205979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-25
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- cf6e1980-932a-4518-a21f-399d08673390
Device Description
Blade #1, 30mm x 180mm
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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63411 | Ophthalmic surgical device handling forceps, reusable | A hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B030SPO1151180 | HIBCC |
Customer Contacts
- Phone
- +1 (484) 427-7060
- [email protected]