FDA UDI
In Commercial Distribution
🇺🇸 United States
DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
DI: 18800018933425
·
Model: 4GS25-1520
·
Dong Bang Medical co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1000
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Basic Information
- Brand Name
- DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
- Primary DI
- 18800018933425
- Version / Model
- 4GS25-1520
- Company Name
- Dong Bang Medical co.,Ltd.
- Labeler DUNS
- 689846367
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2024-10-25
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- f4bdbfbd-b0bc-4482-8369-8b4cd690e64d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | General Hospital | 880.5580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34175 | Acupuncture needle, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28800018933422 | GS1 | outbox | 10000 | In Commercial Distribution | |
| Primary | 18800018933425 | GS1 | ||||
| Package | 38800018933429 | GS1 | 100000 | In Commercial Distribution | ||
| Unit of Use | 08800018933428 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990328 | 000 |