EXEL SPINAL NDL 28GX3-1/2" 26974

GUDID 10020221269748

EXEL SPINAL NDL 28GX3-1/2", 50/BOX,100/CS, 4CS/CRTN

Exel International

Spinal needle, single-use

Primary Device ID	10020221269748
NIH Device Record Key	19519ea9-deb0-46e8-9d77-45b0d01fab3a
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXEL SPINAL NDL 28GX3-1/2"
Version Model Number	26974
Catalog Number	26974
Company DUNS	180572216
Company Name	Exel International
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	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221269741 [Primary]
GS1	10020221269748 [Package] Contains: 00020221269741 Package: Inner box [50 Units] In Commercial Distribution
GS1	20020221269745 [Package] Package: Outer box [2 Units] In Commercial Distribution
GS1	30020221269742 [Package] Contains: 20020221269745 Package: Shipping carton [4 Units] In Commercial Distribution
GS1	40020221269749 [Package] Package: Shipping carton [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K895771

FDA Product Code

FMI	Needle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-03-27
Device Publish Date	2023-03-17

Devices Manufactured by Exel International

10020221260233 - EXEL 1/2mL INS SYR 28GX1/2"	2024-12-03 EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN
20020221260032 - EXEL Comfort Point Insulin Pen Needles	2024-06-26 Insulin Pen Needle, 29G x 1/2
20020221260049 - EXEL Comfort Point Insulin Pen Needles	2024-06-26 Insulin Pen Needle, 31G x 1/4
20020221260056 - EXEL Comfort Point Insulin Pen Needles	2024-06-26 Insulin Pen Needle, 31G x 1/3
20020221260063 - EXEL Comfort Point Insulin Pen Needles	2024-06-26 Insulin Pen Needle, 31G x 1/6
10020221277644 - Exel SecureTouch Safety Blood Collection Set	2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
00020221277661 - Exel SecureTouch Safety Blood Collection Set	2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
00020221277685 - Exel SecureTouch Safety Blood Collection Set	2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube