FDA UDI
In Commercial Distribution
🇺🇸 United States
Life Instruments
DI: M930701211600
·
Model: 701-2116-0
·
Life Instrument Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Life Instruments
- Primary DI
- M930701211600
- Version / Model
- 701-2116-0
- Company Name
- Life Instrument Corporation
- Labeler DUNS
- 948025002
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 1
- Public Version Date
- 2022-02-14
- Public Version Status
- New
- Public Device Record Key
- 13af1267-a2e1-49a3-9cc6-9eaf23f87c8a
Device Description
Shaver 16mm
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
- No
- 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 |
|---|---|---|---|---|
| 44982 | Manual surgical saw blade, flexible, reusable | A flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M930701211600 | HIBCC |