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CAPO Needle

FDA UDI

Class I (US FDA UDI)

by Nexone Bio Co., Ltd.

Identity

Trade Name
CAPO Needle FDA UDI
Generic Name
Bone access cannula FDA UDI
Model / Reference
NOB-VPU11D FDA UDI

Identifiers

Primary DI / UDI-DI
08800046100427 FDA UDI
FDA Product Code
OCJ FDA UDI
GMDN Term
Bone access cannula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone access cannula

CAPO Needle by Nexone Bio Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone access cannula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ac913978-7de2-4757-8451-93b23602ab72 32 fields · synced May 31, 2026