BackVive

FDA UDI

Class I (US FDA UDI)

by Kitotech Medical Inc

Identity

Trade Name: BackVive FDA UDI
Generic Name: Acupuncture needle, single-use FDA UDI
Device Name: Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm) FDA UDI
Model / Reference: P2B1D001 FDA UDI
Description: Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm) FDA UDI

Identifiers

Catalog Number: P2B1D001 FDA UDI
Primary DI / UDI-DI: 00850018777469 FDA UDI
FDA Product Code: KGX FDA UDI
MQX FDA UDI
GMDN Term: Acupuncture needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5240 FDA UDI
880.5580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Acupuncture needle, single-use Adhesive bandage

BackVive by Kitotech Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Kitotech Medical Inc

Sources (1)

FDA UDI 3150ac23-ac48-4065-880f-d144394e906e 36 fields · synced May 31, 2026