11-Gauge Bone Access Needle

FDA UDIEUDAMED

Class I (US FDA UDI)

by Si-Bone Inc.

Identity

Trade Name: 11-Gauge Bone Access Needle FDA UDI
Generic Name: Bone access cannula FDA UDI
Device Name: 11-Gauge Bone Access Needle FDA UDI
Model / Reference: 501820 FDA UDI
Description: 11-Gauge Bone Access Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00810055524464 FDA UDI
FDA Product Code: LXH 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone access cannula

11-Gauge Bone Access Needle by Si-Bone Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bone access cannula.

BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
Arthrex® — Arthrex, Inc. · Class I
Stryker — Provision · Class I
Omnia Medical PsiF — Omnia Medical · Class I
Arthrex® — Arthrex, Inc. · Class I
Omnia Medical Instruments — Omnia Medical · Class I
Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Si-Bone Inc.

Sources (2)

FDA UDI b4681c1c-e1d8-477e-9a98-30c0978af725 34 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026