FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Ruggles®-Redmond™
DI: 10381780154471
·
Model: R1947SL
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Ruggles®-Redmond™
- Primary DI
- 10381780154471
- Version / Model
- R1947SL
- Catalog Number
- R1947SL
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 8
- Public Version Date
- 2023-05-05
- Public Version Status
- Update
- Public Device Record Key
- db433e6c-0526-4f69-94e3-1ac3a63b8985
Device Description
Integra® Ruggles®-Redmond™ Gardner-Wells Traction Tong, 3-7/8", Fixation Screw spring loaded
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
- 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 |
|---|---|---|---|---|
| HBG | DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) | Neurology | 882.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46774 | Surgical retractor/retraction system blade, reusable | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths 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 | M274R1947SL1 | HIBCC | ||||
| Primary | 10381780154471 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]