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SwannShidi

FDA UDI

Class II (US FDA UDI)

by Alliance Partners Llc

Identity

Trade Name
SwannShidi FDA UDI
Generic Name
Bone marrow explant needle FDA UDI
Device Name
Bone Marrow Aspiration Needle FDA UDI
Model / Reference
1110I-1000 FDA UDI
Description
Bone Marrow Aspiration Needle FDA UDI

Identifiers

Primary DI / UDI-DI
M6861110I10000 FDA UDI
510(k) Number
K121181 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Bone marrow explant needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 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 — 15 Gauge FDA UDI

Category: Bone marrow explant needle

SwannShidi by Alliance Partners Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone marrow explant needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alliance Partners Llc

Sources (1)

  • FDA UDI 98717177-e896-4374-b7fa-26f5f8aea176 36 fields · synced May 31, 2026