Identity
- Trade Name
- Biotronix Healthcare Syringes FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Disposable .30CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag FDA UDI
- Model / Reference
- GE12011 FDA UDI
- Description
- Disposable .30CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag FDA UDI
Identifiers
- Catalog Number
- GE12011 FDA UDI
- Primary DI / UDI-DI
- 00858835007370 FDA UDI
- 510(k) Number
- K110421 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hypodermic needle, single-useGeneral-purpose syringe, single-use
Biotronix Healthcare Syringes by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110421 also covers:
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Biotronix Healthcare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Easy Glide INSULIN SYRIN 0.3 ML 29GX1/2" — GLOBAL DIABETIC DISTRIBUTORS INC
- Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2" — GLOBAL DIABETIC DISTRIBUTORS INC
- Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2" 1/2 UNIT MARKING — GLOBAL DIABETIC DISTRIBUTORS INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI 20e5e97d-9ed8-48a6-824e-b72d80fcab1c 37 fields · synced May 30, 2026