Identity
- Trade Name
- ProCure™ FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- ProCure Safe TB Tuberculin Safety Syringe 1ml 27g x 1/2" - 100ea/bx 8bx/cs FDA UDI
- Model / Reference
- PCSS735 FDA UDI
- Description
- ProCure Safe TB Tuberculin Safety Syringe 1ml 27g x 1/2" - 100ea/bx 8bx/cs FDA UDI
Identifiers
- Catalog Number
- PCSS735 FDA UDI
- Primary DI / UDI-DI
- 10840330703656 FDA UDI
- 510(k) Number
- K150758 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Insulin syringe/needle, safety 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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Inch FDA UDINeedle Gauge — 27 Gauge FDA UDIOuter Diameter — .5 Inch FDA UDITotal Volume — 1 Milliliter FDA UDI
Category: Insulin syringe/needle, safety
ProCure™ by Twin Med, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
Cleared under the same submission
K150758 also covers:
- Glucertain — CellEra, LLC
- Glucertain — CellEra, LLC
- Secure Safe Allergy Tray — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- MEDLINE — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, 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
- Twin Med, LLC
Sources (1)
- FDA UDI ce2e31d5-600b-439a-b558-a73371f3daa7 38 fields · synced Jun 1, 2026