FDA UDI
In Commercial Distribution
🇺🇸 United States
Haritex Corporation
DI: 04719880180516
·
Model: HC-57
·
HARITEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- Haritex Corporation
- Primary DI
- 04719880180516
- Version / Model
- HC-57
- Catalog Number
- HC-57
- Company Name
- HARITEX CORPORATION
- Labeler DUNS
- 656398765
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 1
- Public Version Date
- 2023-07-19
- Public Version Status
- New
- Public Device Record Key
- 24197e6f-b8f1-4fe7-8268-f91db5c1d0bf
Device Description
FORCEPS WIRE HEMO KELLY STR 5-1/2", 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
- Yes
- 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 |
|---|---|---|---|---|
| HRQ | Hemostat | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40589 | Medical tubing clip/clamp, temporary, non-calibrated, single-use | A manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719880180513 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 04719880180516 | GS1 | ||||
| Unit of Use | 04719880180509 | GS1 |