FDA.reportPublic FDA data

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

Primary DI
18800018933401
Brand
DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
Company
Dong Bang Medical co.,Ltd.
Model
4GS22-3025
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990328000DBC, DONG BANG ACUPUNCTURE NEEDLESMorning Star, Dong Bang Acupuncture U.S.A., Inc.1999-05-04MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800018933408PackageGS110000In Commercial Distribution
38800018933405PackageGS1100000In Commercial Distribution
18800018933401PrimaryGS10
08800018933404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880001893340828800018933408
3880001893340538800018933405
1880001893340118800018933401
08800018933404088000189334048800018933404

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Regulatory Flags#

DUNS number
689846367
Device count
1000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18800018909024DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS20-30252024-10-25
18800018909031DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS20-40252024-10-25
18800018909048DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS25-30252024-10-25
18800018909055DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS25-40252024-10-25
18800018909062DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS30-40252024-10-25
18800018909970DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS30-30252024-10-25
18800018933173DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS16-15202024-10-25
18800018933180DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS16-30252024-10-25
18800018933197DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS18-15202024-10-25
18800018933203DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS18-30252024-10-25
18800018933210DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS18-40252024-10-25
18800018933227DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS20-15202024-10-25
18800018933388DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS20-50252024-10-25
18800018933395DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS22-15202024-10-25
18800018933418DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS22-40252024-10-25
18800018933425DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS25-15202024-10-25
18800018933432DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS25-50252024-10-25
18800018933449DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS25-60252024-10-25
18800018933456DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS30-50252024-10-25
18800018933463DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS30-60252024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023361HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023385HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023392HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023415HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023422HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023576SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
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00816073023644HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023651HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023675HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023682HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023699HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
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00816073023729HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023736HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023743HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023750HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023767HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073024221SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024344SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024351SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024481SILVERSTARHealth Body World Supply Inc.MQX2026-06-23