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Sheathes

FDA UDI

Class II (US FDA UDI)

by Sheathing Technologies, Inc.

Identity

Trade Name
Sheathes FDA UDI
Generic Name
Ultrasound/electromagnetic-guided needle kit FDA UDI
Device Name
Polyurethane, 6"W x 48"L, Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5, & 2.0cm), Tilt-Out Style FDA UDI
Model / Reference
65-486-12110-3 FDA UDI
Description
Polyurethane, 6"W x 48"L, Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5, & 2.0cm), Tilt-Out Style FDA UDI

Identifiers

Primary DI / UDI-DI
10842418103938 FDA UDI
FDA Product Code
OIJ FDA UDI
GMDN Term
Ultrasound/electromagnetic-guided needle kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 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

No

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

No

FDA UDI

Category: Ultrasound/electromagnetic-guided needle kit

Sheathes by Sheathing Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound/electromagnetic-guided needle kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sheathing Technologies, Inc.

Sources (1)

  • FDA UDI aa5e32d2-3733-460a-be8a-a7e4f741e2ab 33 fields · synced Jun 9, 2026