DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)

GUDID 28800018933446

Dong Bang Medical co.,Ltd.

Acupuncture needle, single-use
Primary Device ID28800018933446
NIH Device Record Key19746235-d5c9-4de1-83de-3fe61ea5397f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
Version Model Number4GS25-6025
Company DUNS689846367
Company NameDong Bang Medical co.,Ltd.
Device Count1000
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018933442 [Unit of Use]
GS118800018933449 [Primary]
GS128800018933446 [Package]
Contains: 18800018933449
Package: outbox [10000 Units]
In Commercial Distribution
GS138800018933443 [Package]
Package: carton box [100000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQXNeedle, Acupuncture, Single Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-04
Device Publish Date2024-10-25

On-Brand Devices [DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)]

288000189334604GS30-6025
288000189334534GS30-5025
288000189334464GS25-6025
288000189334394GS25-5025
288000189334224GS25-1520
288000189334154GS22-4025
288000189334084GS22-3025
288000189333924GS22-1520
288000189333854GS20-5025
288000189332244GS20-1520
288000189332174GS18-4025
288000189332004GS18-3025
288000189331944GS18-1520
288000189331874GS16-3025
288000189331704GS16-1520
288000189099774GS30-3025
288000189090694GS30-4025
288000189090524GS25-4025
288000189090454GS25-3025
288000189090384GS20-4025
288000189090214GS20-3025

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