BioCare Safety Needles K112057

GUDID 20858835007770

Disposable BioCare Safety Needles 23G x 1 1/2"

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use

Primary Device ID	20858835007770
NIH Device Record Key	ec8892f4-9be2-4a1b-9b47-62b3d192b6d4
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioCare Safety Needles
Version Model Number	K112057
Catalog Number	K112057
Company DUNS	065762392
Company Name	BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00858835007776 [Primary]
GS1	10858835007773 [Package] Contains: 00858835007776 Package: Inner Box [100 Units] In Commercial Distribution
GS1	20858835007770 [Package] Contains: 10858835007773 Package: Case [8 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112057

FDA Product Code

FMI	Needle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-12-24
Device Publish Date	2019-10-10

On-Brand Devices [BioCare Safety Needles]

20858835007770	Disposable BioCare Safety Needles 23G x 1 1/2"
20858835007763	Disposable BioCare Safety Needles 21G x 1 1/2"
20858835007756	Disposable BioCare Safety Needles 20G x 1 1/2"
20858835007114	Disposable BioCare Safety Needles 23G x 1"
20858835007091	Disposable BioCare Safety Needles 30G x 1/2"
20858835007084	Disposable BioCare Safety Needles 22G x 1 1/2"
30858835007074	Disposable BioGuard Safety Needles 18G x 1 1/2",