FDA UDI In Commercial Distribution 🇺🇸 United States

BON Spring Needles

DI: 06977427142788 · Model: 0.16*15mm · Changchun AIK Medical Devices Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1000

Basic Information

Brand Name
BON Spring Needles
Primary DI
06977427142788
Version / Model
0.16*15mm
Company Name
Changchun AIK Medical Devices Co., Ltd.
Labeler DUNS
543439762
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2025-07-15
Public Version
1
Public Version Date
2025-07-23
Public Version Status
New
Public Device Record Key
8802f8bb-d929-49e3-ae12-1eb9c9f01c82

Device Description

STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE are manufactured from stainless steel .Ten needles with one tube per sterile, individually blister package, 1000 needles per box

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MQX Needle, Acupuncture, Single Use

GMDN Terms

Code Name
34175 Acupuncture needle, single-use

Identifiers

Type ID
Package 26977427142782
Unit of Use 86977427142784
Package 36977427142789
Primary 06977427142788

Premarket Submissions

Submission Number Supplement Number
K162566 000