FDA UDI
In Commercial Distribution
🇺🇸 United States
SURJEX
DI: G383HARTMANNMOSQUITORE6
·
Model: 7-24
·
SURJEX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SURJEX
- Primary DI
- G383HARTMANNMOSQUITORE6
- Version / Model
- 7-24
- Catalog Number
- 7-24
- Company Name
- SURJEX
- Labeler DUNS
- 645518882
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-31
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- 2b65c9a4-df36-4641-a6a9-44fe6b602a92
Device Description
Hartmann Mosquito Straight 3.5",
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42468 | Clamp manipulation forceps | A hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G383HARTMANNMOSQUITORE6 | HIBCC |