FDA.reportPublic FDA data

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

Primary DI
28800018909069
Brand
DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
Company
Dong Bang Medical co.,Ltd.
Model
4GS30-4025
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
28800018909069PackageGS110000In Commercial Distribution
38800018909066PackageGS1100000In Commercial Distribution
18800018909062PrimaryGS10
08800018909065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880001890906928800018909069
3880001890906638800018909066
1880001890906218800018909062
08800018909065088000189090658800018909065

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689846367
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
18800018933401DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)4GS22-30252024-10-25
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

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