FDA.reportPublic FDA data

Nano Tech Bulk

Primary DI
38800018900780
Brand
Nano Tech Bulk
Company
Dong Bang Medical co.,Ltd.
Model
Ntb.30x50
Catalog number
Ntb.30x50
Device description
Nano Tech™ Bulk Five Acupuncture Needles are precisely calibrated for ease and accuracy, Nano Tech™ Bulk Five needles have been completely re-engineer
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
28800018900783PackageGS110In Commercial Distribution
38800018900780PackageGS110In Commercial Distribution
18800018900786PrimaryGS10
08800018900789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880001890078328800018900783
3880001890078038800018900780
1880001890078618800018900786
08800018900789088000189007898800018900789

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
500
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
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27