FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline ReNewal
DI: 10888277354692
·
Model: REP112994
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline ReNewal
- Primary DI
- 10888277354692
- Version / Model
- REP112994
- Catalog Number
- REP112994
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 4
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- ec7603d4-990b-436b-9481-f84215b51765
Device Description
72203013 PLATINUM, INCISORPLS BLADE, (S
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61800 | Arthroscopic shaver system blade, reprocessed | A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888277354692 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.5 | Millimeter |