FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10193489000962
·
Model: MPP2200R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10193489000962
- Version / Model
- MPP2200R
- Catalog Number
- MPP2200R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-06
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- a7b898f2-6ee4-4013-8c52-e99b391a00e5
Device Description
PLATE, LAPIDUS, DUAL MODE COMP, RIGHT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61671 | Orthopaedic bone washer, sterile | A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device. | No | Obsolete |
| 47996 | Orthodontic anchor plate | A small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10193489000962 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]