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Harvest Needle

FDA UDI

Class II (US FDA UDI)

by H.s. Hospital Service Spa

Identity

Trade Name
HARVEST NEEDLE FDA UDI
Generic Name
Bone marrow explant needle FDA UDI
Device Name
HARVEST NEEDLE 11GX100MM FDA UDI
Model / Reference
HARVEST NEEDLE FDA UDI
Description
HARVEST NEEDLE 11GX100MM FDA UDI

Identifiers

Catalog Number
ES1110PD FDA UDI
Primary DI / UDI-DI
08033003342343 FDA UDI
510(k) Number
K013070 FDA UDI
FDA Product Code
FCG 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 100 Millimeter FDA UDI
Needle Gauge — 11 Gauge FDA UDI

Category: Bone marrow explant needle

Harvest Needle by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone marrow explant needle.

Cleared under the same submission

K013070 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H.s. Hospital Service Spa

Sources (1)

  • FDA UDI 41c23bc6-73a3-4a4f-9ede-e922396c54a9 37 fields · synced May 30, 2026