Identity
- Trade Name
- Wealy® RELI® FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- Safety Syringe w/ Ndl, 10ML, 22G x 1.5" FDA UDI
- Model / Reference
- SS10ML22G151 FDA UDI
- Description
- Safety Syringe w/ Ndl, 10ML, 22G x 1.5" FDA UDI
Identifiers
- Catalog Number
- SS10ML22G151 FDA UDI
- Primary DI / UDI-DI
- 00386120009100 FDA UDI
- 510(k) Number
- K141640 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe 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
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
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDITotal Volume — 10 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe
Wealy® RELI® by Myco Medical Supplies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe.
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- Monoject — Cardinalhealth · Class II
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Cleared under the same submission
K141640 also covers:
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES 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
- Myco Medical Supplies Inc.
Sources (1)
- FDA UDI 618b9592-4691-4acd-be92-1f8566771a5f 36 fields · synced May 31, 2026