FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04719880180189
·
Model: HC-52
·
HARITEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- NA
- Primary DI
- 04719880180189
- Version / Model
- HC-52
- Company Name
- HARITEX CORPORATION
- Labeler DUNS
- 656398765
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- 1bbe7d74-0ea4-4948-b3b9-06e62963660b
Device Description
FORCEPS THUMB WIRE W/SERRATED INST. 5" SINGLE USE
Device Characteristics
- Single Use
- Yes
- 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
- No
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 |
|---|---|---|---|---|
| 62489 | Dressing/utility forceps, tweezers-like, single-use | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04719880180400 | GS1 | ||||
| Primary | 04719880180189 | GS1 | ||||
| Package | 14719880180186 | GS1 | Carton | 4 | In Commercial Distribution |