Baby Gorilla/Gorilla Plating System
- Primary DI
- 00889795041012
- Brand
- Baby Gorilla/Gorilla Plating System
- Company
- PARAGON 28, INC.
- Model
- P99-150-0081
- Catalog number
- P99-150-0081
- Device description
- Harris-Yoon Mini Pin Distractor
- Published
- 2019-10-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00889795041012 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00889795041012 | 00889795041012 | 889795041012 | 0889795041012 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone distraction forceps | A hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 042961576
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
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| 00889795153852 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-2 | P50-900-BGSL-2 | 2026-02-19 |
| 00889795153883 | Baby Gorilla/Gorilla Plating System | P50-900-BGSL-3 | P50-900-BGSL-3 | 2026-02-19 |
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| 00889795153906 | Baby Gorilla/Gorilla Plating System | P50-900-SBSL-1 | P50-900-SBSL-1 | 2026-02-19 |
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