Identity
- Trade Name
- Rospital Productos Medicos FDA UDI
- Generic Name
- Tuberculin/allergy syringe/needle, basic FDA UDI
- Device Name
- 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 27G X 1/2 IN EACH, FDA UDI
- Model / Reference
- TB127 FDA UDI
- Description
- 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 27G X 1/2 IN EACH, FDA UDI
Identifiers
- Catalog Number
- TB127 FDA UDI
- Primary DI / UDI-DI
- 00812460026885 FDA UDI
- 510(k) Number
- K060211 FDA UDI
- FDA Product Code
- FMF FDA UDIFMI FDA UDI
- GMDN Term
- Tuberculin/allergy syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 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
No
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: Tuberculin/allergy syringe/needle, basic
Rospital Productos Medicos by Atlas Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tuberculin/allergy syringe/needle, basic.
- Metier — Jiangsu Caina Medical Co., Ltd · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Metier — Jiangsu Caina Medical Co., Ltd · Class II
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
Cleared under the same submission
K060211 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
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atlas Medical Products Llc
Sources (1)
- FDA UDI a828a2d3-1263-4e05-89fe-ba8a5bc963ec 37 fields · synced May 30, 2026