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Rbn-114s

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 74092-01MModel Ranfac Marrow Biopsy Needle

by Ranfac Corp.

Identity

Trade Name
RBN-114S EUDAMED
NDL, RBN-114S, STERILE, F/G FDA UDI
Generic Name
Bone marrow biopsy needle, single-use FDA UDI
Device Name
RBN-84 EUDAMED
RBN-114S P/N 74092-01M FDA UDI
Model / Reference
Ranfac Marrow Biopsy Needle EUDAMED
74092-01M EUDAMED
11GA X 4" FDA UDI
Description
RBN-114S P/N 74092-01M FDA UDI

Identifiers

Catalog Number
RBN-114S FDA UDI
Primary DI / UDI-DI
00858690006044 EUDAMEDFDA UDI
Basic UDI-DI
08586900068300701H3 EUDAMED
Direct Marketing DI
00858690006044 EUDAMED
510(k) Number
K983187 FDA UDI
FDA Product Code
KNW FDA UDI
EMDN Code
A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
GMDN Term
Bone marrow biopsy needle, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Market of Registration
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
Length — 4 Inch FDA UDI
Needle Gauge — 11 Gauge FDA UDI

Rbn-114s by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ranfac Corp.
EUDAMED SRN
US-MF-000008871
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 2dc3398e-f844-4487-885b-a36d48b99f73 61 fields · synced Jun 19, 2026
  • FDA UDI 6ace3764-1a9e-459c-8851-fd5193ac1596 37 fields · synced May 29, 2026