Durasphere ®

FDA UDI

Class II (US FDA UDI)

by Carbon Medical Technologies, Inc.

Identity

Trade Name: Durasphere ® FDA UDI
Generic Name: Submucosal injection needle FDA UDI
Device Name: Injection Needle, Spinal Tip FDA UDI
Model / Reference: 890-205 FDA UDI
Description: Injection Needle, Spinal Tip FDA UDI

Identifiers

Catalog Number: 890-205 FDA UDI
Primary DI / UDI-DI: 00858015005615 FDA UDI
FDA Product Code: FBK FDA UDI
GMDN Term: Submucosal injection needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 15 Inch FDA UDI
Needle Gauge — 18 Gauge FDA UDI

Category: Submucosal injection needle

Durasphere ® by Carbon Medical Technologies, Inc. — 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

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: Carbon Medical Technologies, Inc.

Sources (1)

FDA UDI 5e9c53c4-9474-427a-91c4-1d67231b95fe 37 fields · synced Jun 9, 2026