FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Ruggles®-Redmond™
DI: 10381780167860
·
Model: RN6200
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Ruggles®-Redmond™
- Primary DI
- 10381780167860
- Version / Model
- RN6200
- Catalog Number
- RN6200
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-22
- Public Version
- 4
- Public Version Date
- 2023-05-12
- Public Version Status
- Update
- Public Device Record Key
- 2b334832-9845-40e1-bc6b-982492a46030
Device Description
Integra® Ruggles®-Redmond™ Rhoton-Type Microsurgery Dissection Set, 15 Instruments and Tray
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OJG | Neurological tray | Neurology | 882.4525 | 1 |
| GZX | INSTRUMENT, MICROSURGICAL | Neurology | 882.4525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44065 | Neurosurgical procedure kit, non-medicated, reusable | A collection of various neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
| 11290 | Open-surgery dissector | A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M274RN62001 | HIBCC | ||||
| Primary | 10381780167860 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]