Medline ReNewal
- Primary DI
- 10888277354579
- Brand
- Medline ReNewal
- Company
- MEDLINE INDUSTRIES, INC.
- Model
- REP110512
- Catalog number
- REP110512
- Device description
- 375-953-000 FRML BARREL BUR, 6-FLT LT H
- Published
- 2016-10-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HRX | Arthroscope | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10888277354579 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10888277354579 | 10888277354579 |
GMDN Terms
| Term | Definition |
|---|
| Arthroscopic shaver system blade, reprocessed | A sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a previously used single-use device that has been processed for an additional single-use patient application. |
Device Sizes
| Type | Value | Unit |
|---|
| Outer Diameter | 5.5 | Millimeter |
Regulatory Flags
- DUNS number
- 025460908
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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