FDA UDI
In Commercial Distribution
🇺🇸 United States
SpaceVision® PLIF
DI: 03663136028262
·
Model: PL1-C07-25-00
·
SPINEVISION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpaceVision® PLIF
- Primary DI
- 03663136028262
- Version / Model
- PL1-C07-25-00
- Company Name
- SPINEVISION
- Labeler DUNS
- 390377518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9c6ee688-bebd-44bd-b076-d149958a6373
Device Description
PLIF cage H07-L25-A00
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
- No
- 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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60764 | Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple bacteria associated with respiratory disease in a clinical specimen, and/or one or multiple genes conferring antimicrobial resistance in the respiratory isolates detected, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, C. pneumoniae (Chlamydia pneumoniae), Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03663136028262 | GS1 |
Customer Contacts
- Phone
- +33153332525
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 00 | degree | |
| Length | 21 | Millimeter | |
| Height | 08 | Millimeter |