Identity
- Trade Name
- DOPE DOCTORS FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- The disposable insulin syringe is intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. FDA UDI
- Model / Reference
- 0.3ml 31Gx5/16" FDA UDI
- Description
- The disposable insulin syringe is intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. FDA UDI
Identifiers
- Catalog Number
- DC023318 FDA UDI
- Primary DI / UDI-DI
- 06971564467834 FDA UDI
- 510(k) Number
- K151949 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic 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
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: Insulin syringe/needle, basic
Dope Doctors by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
- EasyTouch — MHC Medical Products · Class II
- EasyTouch — MHC Medical Products · Class II
- BH Supplies — ANREL DISTRIBUTION LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON AND COMPANY · Class II
- droplet insulin syringes — HTL STREFA S A · Class II
- Insulin Syringe — Dynarex Corp. · Class II
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K151949 also covers:
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- DOPE DOCTORS — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI c8740b10-9d23-41b5-8693-c36ccfbbbaf6 35 fields · synced Jun 1, 2026