FDA UDI
In Commercial Distribution
🇺🇸 United States
RENOIR Posterior Cervico-Thoracic Fixation System
DI: 00841732104686
·
Model: 012.7012
·
CTL MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RENOIR Posterior Cervico-Thoracic Fixation System
- Primary DI
- 00841732104686
- Version / Model
- 012.7012
- Company Name
- CTL MEDICAL CORPORATION
- Labeler DUNS
- 080138504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-05
- Public Version
- 3
- Public Version Date
- 2021-09-20
- Public Version Status
- Update
- Public Device Record Key
- 8676eeb1-a5f6-42db-a473-57df82257559
Device Description
Drill, D2.6 x L14mm
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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36235 | Manual surgical rotary handpiece, reusable | A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841732104686 | GS1 |
Customer Contacts
- Phone
- +1(214)545-5820
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Millimeter | |
| Device Size Text, specify | D2.6 |