FDA UDI
In Commercial Distribution
🇺🇸 United States
Conformis Hip System
DI: M572HAR000S144011
·
Model: HAR000S14401
·
Conformis, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Conformis Hip System
- Primary DI
- M572HAR000S144011
- Version / Model
- HAR000S14401
- Catalog Number
- HAR000S144
- Company Name
- Conformis, Inc.
- Labeler DUNS
- 808821883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-02
- Public Version
- 4
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 01b3ff55-0482-4e2f-b2b7-c10e1e2c6cd1
Device Description
HIP-REAMER STAGE 1-44MM
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61807 | Bone-resection orthopaedic reamer, single-use | An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M572HAR000S144011 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 44 | Millimeter |