FDA.reportPublic FDA data

DBC Spring Single

Primary DI
38800018900193
Brand
DBC Spring Single
Company
Dong Bang Medical co.,Ltd.
Model
dST.22x50
Catalog number
dST.22x50
Device description
DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring" style metal handle. T
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
28800018900196PackageGS110In Commercial Distribution
38800018900193PackageGS120In Commercial Distribution
18800018900199PrimaryGS10
08800018900192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880001890019628800018900196
3880001890019338800018900193
1880001890019918800018900199
08800018900192088000189001928800018900192

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-722-8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
689846367
Device count
100
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818318024027Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00818318024126Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01