FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyTouch
DI: MHC14233252
·
Model: 423325
·
MHC MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- EasyTouch
- Primary DI
- MHC14233252
- Version / Model
- 423325
- Company Name
- MHC MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 169895245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 42904337-52d6-4683-b13a-eba846a8b595
Device Description
ET 23G 1 in 3mL Auto Retract Syringe [TB]
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32592 | Tuberculin/allergy syringe/needle, safety | A sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle can be fully retracted into the barrel, providing protection against needle sticks and rendering the device unusable. 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 | MHC14233250 | HIBCC | ||||
| Primary | MHC14233252 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141640 | 000 |