FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hysynal
DI: 10087453143475
·
Model: 14347
·
HYGENIC CORPORATION, THE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
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Basic Information
- Brand Name
- Hysynal
- Primary DI
- 10087453143475
- Version / Model
- 14347
- Company Name
- HYGENIC CORPORATION, THE
- Labeler DUNS
- 004163390
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2019-04-18
- Public Version
- 5
- Public Version Date
- 2025-03-11
- Public Version Status
- Update
- Public Device Record Key
- 66c22c43-b418-4cb7-b477-8b532160eb44
- Distribution End Date
- 2025-03-10
Device Description
1" HYSYNAL SYNTHETIC TOURNIQUET STRAPS PERFORATED 25/RL, 4RL/BOX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35925 | Tourniquet cuff, single-use | A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10087453143475 | GS1 | ||||
| Unit of Use | 20087453143472 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18 | Inch | |
| Width | 1 | Inch |