← Back to catalogue

Infiniti Plus™ Needle Guide

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 610-1214

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Infiniti Plus™ Needle Guide EUDAMEDFDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
General Purpose Guidance – In-Plane, Open Channel (Infiniti plus guide) EUDAMED
Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer cover FDA UDI
Model / Reference
610-1214 EUDAMED
610-1214, 610-1214-5 FDA UDI
Description
Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer cover FDA UDI

Identifiers

Catalog Number
610-1214, 610-1214-5 FDA UDI
Primary DI / UDI-DI
10841436102473 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD101C1ND EUDAMED
510(k) Number
K093713 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
A018002 NEEDLE GUIDES EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany 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

No

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

Yes

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 3.6 Inch FDA UDI
Width — 2.8 Inch FDA UDI

Infiniti Plus™ Needle Guide by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K093713 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (2)

  • FDA UDI 3ef68824-bcdc-4b2b-8696-60f6fb9d1b95 38 fields · synced Oct 6, 2026
  • EUDAMED 732c418b-4fa9-47c5-8fee-9ba2f1218c61 61 fields · synced Aug 3, 2026