Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Tuberculin/allergy syringe/needle, basic FDA UDI
- Device Name
- DBD-ALLERGY TRAY, 26GX3/8", 1ML FDA UDI
- Model / Reference
- SYRA101261 FDA UDI
- Description
- DBD-ALLERGY TRAY, 26GX3/8", 1ML FDA UDI
Identifiers
- Catalog Number
- SYRA101261 FDA UDI
- Primary DI / UDI-DI
- 10888277654075 FDA UDI
- FDA Product Code
- FPA FDA UDIFMF FDA UDI
- GMDN Term
- Tuberculin/allergy syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI880.5860 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 26 Gauge FDA UDILength — 0.375 Inch FDA UDI
Category: Tuberculin/allergy syringe/needle, basic
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tuberculin/allergy syringe/needle, basic.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
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Cleared under the same submission
K113091 also covers:
- Monoject — Cardinalhealth
- Allergy Tray — Dynarex Corp.
- Syringe 3ml — GERI-GENTLE CORPORATION
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
K151991 also covers:
- 8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/ — Dynarex Corp.
- 8944 SecureSafe Safety Blood Collection Set w/ Tube Holder, 23G, 3/4" Needle, 4/ — Dynarex Corp.
- 8945 SecureSafe Safety Blood Collection Set w/ Tube Holder, 25G, 3/4" Needle, 4/ — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical 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 |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 67a70064-680d-49a2-aacf-b9d373376a97 37 fields · synced Jun 8, 2026