FDA UDI
In Commercial Distribution
🇺🇸 United States
Gen2
DI: 00840343701543
·
Model: G2N11109
·
SURGIX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Gen2
- Primary DI
- 00840343701543
- Version / Model
- G2N11109
- Catalog Number
- G2N11109
- Company Name
- SURGIX MEDICAL LLC
- Labeler DUNS
- 080402644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-19
- Public Version
- 2
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- 2b6c9879-cee9-4f7f-b7a1-2d441f0e737c
Device Description
CUSHING, GASSERIAN GANGLION HOOK BLUNT 9"
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42595 | Soft-tissue surgical hook, reusable | A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840343701543 | GS1 | ||||
| Previous | G277G2N111090 | HIBCC |
Customer Contacts
- Phone
- 888-247-0477
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Inch |