FDA UDI
In Commercial Distribution
🇺🇸 United States
Clinical HypoHolder
DI: 00860010987940
·
Model: 1004
·
TyTek Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Clinical HypoHolder
- Primary DI
- 00860010987940
- Version / Model
- 1004
- Company Name
- TyTek Medical Inc.
- Labeler DUNS
- 078589992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-27
- Public Version
- 2
- Public Version Date
- 2025-07-07
- Public Version Status
- Update
- Public Device Record Key
- 42c5af35-9186-4f3d-88ca-2883ef825816
Device Description
Non-sterile pin base for use in clinical setting
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37461 | Needle recapping device, reusable | A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010987940 | GS1 |