FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00849044042528
·
Model: 675.710
·
GLOBUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00849044042528
- Version / Model
- 675.710
- Company Name
- GLOBUS MEDICAL, INC.
- Labeler DUNS
- 139105691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 465de018-9e8c-4e36-9f2a-56c7447c46ee
Device Description
Blade, Lateral, 100mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42600 | Abdominal retractor, self-retaining, fixed | A self-locking, surgical instrument used to separate the margins of an abdominal incision typically during deep or extensive surgery, to expose or access organs or tissues for examination or intervention. The instrument has a flat, blunt-edged blade that may curve acutely to form a saddle-shaped hook, or it may have an L-shaped form; it has a series of eyeholes or notches at the distal end where it can be suspended from or placed in a fixation device to secure its position. It is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849044042528 | GS1 |
Customer Contacts
- Phone
- +1(610)930-1800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Millimeter |