Identity
- Trade Name
- Barrigel Applicator Needle FDA UDI
- Generic Name
- Submucosal injection needle FDA UDI
- Device Name
- Barrigel applicator needle FDA UDI
- Model / Reference
- 3009-2 FDA UDI
- Description
- Barrigel applicator needle FDA UDI
Identifiers
- Catalog Number
- 3009-2 FDA UDI
- Primary DI / UDI-DI
- 00850004725115 FDA UDI
- 510(k) Number
- K220641 FDA UDI
- FDA Product Code
- OVB FDA UDI
- GMDN Term
- Submucosal injection needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5725 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 — 18 Gauge FDA UDILength — 20 Centimeter FDA UDI
Category: Submucosal injection needle
Barrigel Applicator Needle by Palette Life Sciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal injection needle.
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K220641 also covers:
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
- Palette Life Sciences
Sources (1)
- FDA UDI 6f02f7dc-f420-4443-8df9-1553e919f883 37 fields · synced Jun 8, 2026