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Wallach EndoBlock Needle

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Wallach EndoBlock Needle FDA UDI
Generic Name
Cervical anaesthesia needle, single-use FDA UDI
Device Name
Endocervical Block Needle with Luer Lock Hub FDA UDI
Model / Reference
920017 FDA UDI
Description
Endocervical Block Needle with Luer Lock Hub FDA UDI

Identifiers

Primary DI / UDI-DI
20888937011207 FDA UDI
510(k) Number
K021224 FDA UDI
FDA Product Code
HEE FDA UDI
GMDN Term
Cervical anaesthesia needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5100 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

Category: Cervical anaesthesia needle, single-use

Wallach EndoBlock Needle by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical anaesthesia needle, single-use.

Cleared under the same submission

K021224 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI a845a0cb-ae5a-4b4b-a870-6ff43369625f 34 fields · synced Jun 9, 2026