FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ENDOSKELETON® Sterile Barrier System
DI: 00191375011972
·
Model: 1130-1010
·
TITAN SPINE, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOSKELETON® Sterile Barrier System
- Primary DI
- 00191375011972
- Version / Model
- 1130-1010
- Catalog Number
- 1130-1010
- Company Name
- TITAN SPINE, LLC
- Labeler DUNS
- 623316978
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 12
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 2ce143f1-5967-4dd7-895f-6ca75f7eb58a
- Distribution End Date
- 2020-09-18
Device Description
Caddy, Large
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
| OVD | Intervertebral fusion device with integrated fixation, lumbar | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral fusion device with bone graft, cervical | Orthopedic | 888.3080 | 2 |
| MQP | Spinal vertebral body replacement device | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191375011972 | GS1 |
Customer Contacts
- Phone
- +1(262)242-7801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142589 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Caddy, Large |