FDA UDI
In Commercial Distribution
🇺🇸 United States
ELITE MEDICAL INSTRUMENTATION
DI: G569EMIMD5620
·
Model: EMI-MD562
·
ELITE MEDICAL INSTRUMENTATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELITE MEDICAL INSTRUMENTATION
- Primary DI
- G569EMIMD5620
- Version / Model
- EMI-MD562
- Catalog Number
- EMI-MD562 NERVE HOOK
- Company Name
- ELITE MEDICAL INSTRUMENTATION
- Labeler DUNS
- 116733674
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-27
- Public Version
- 1
- Public Version Date
- 2024-03-06
- Public Version Status
- New
- Public Device Record Key
- 4e1f62dd-d4c4-4d42-b9f0-a40db4fcad4c
Device Description
Hook, Dandy, Nerve, Blunt, 90deg, 8 3/4"
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
- Yes
- 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 |
|---|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35335 | Dura mater dissector | A hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft that terminates at the distal end with a rounded curved tip, or it can be double-ended. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G569EMIMD5620 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.75 | Inch |