FDA UDI
In Commercial Distribution
🇺🇸 United States
Monkey Bars™ Pin to Bar External Fixation System
DI: 00889795114709
·
Model: P47-230-0525
·
Paragon 28, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Monkey Bars™ Pin to Bar External Fixation System
- Primary DI
- 00889795114709
- Version / Model
- P47-230-0525
- Catalog Number
- P47-230-0525
- Company Name
- Paragon 28, Inc.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 4
- Public Version Date
- 2025-09-23
- Public Version Status
- Update
- Public Device Record Key
- 3602cff4-eeae-4896-aa48-b9a2b26d8dd9
Device Description
5mm Pin Cap (10 Pack)
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58959 | Pin-sleeve orthopaedic bone screw | An implantable device comprising a small, threaded, cannulated sleeve containing a pin fixed inside at its distal end, intended to be used to hold a bone plate in place for internal orthopaedic fracture fixation. It is anchored to bone by the external thread on the sleeve and to the fixation plate by the thread on the head of the pin. It is intended to provide compression of the fracture site and to allow micro-movement for even distribution of load across the fixation plate to promote symmetrical callus formation. It is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)]. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889795114709 | GS1 | ||||
| Unit of Use | 70889795114708 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211112 | 000 |