Identity
- Trade Name
- SHARD FDA UDI
- Generic Name
- Medication transfer needle, non-filtering/non-vented FDA UDI
- Device Name
- SHARD Hypodermic Needles 27G*13mm (1/2") Thin wall. FDA UDI
- Model / Reference
- N-TW2713 FDA UDI
- Description
- SHARD Hypodermic Needles 27G*13mm (1/2") Thin wall. FDA UDI
Identifiers
- Catalog Number
- N-TW2713 FDA UDI
- Primary DI / UDI-DI
- 00814639025422 FDA UDI
- 510(k) Number
- K072739 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Medication transfer needle, non-filtering/non-vented 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
Yes
FDA UDI
Category: Medication transfer needle, non-filtering/non-vented
Shard by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer needle, non-filtering/non-vented.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Medic Anti-stick Needle/Connector — NxStage Medical, Inc. · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- Monoject — Cardinalhealth · Class I
- Ceros — RHINO MEDICAL SUPPLY INC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class I
Cleared under the same submission
K072739 also covers:
- SHARD — APPLIED DENTAL, INC.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
- WEGO — Shandong Weigao Group Medical Polymer Co., Ltd.
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
- Applied Dental, Inc.
Sources (1)
- FDA UDI a2b250c4-76dd-4768-8991-b6d0a6a27c84 37 fields · synced Jun 8, 2026