FDA UDI
In Commercial Distribution
🇺🇸 United States
KM NEEDLE
DI: 18800020500080
·
Model: KMS GS0256020
·
K. M. S
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- KM NEEDLE
- Primary DI
- 18800020500080
- Version / Model
- KMS GS0256020
- Company Name
- K. M. S
- Labeler DUNS
- 689846211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 63724a29-7553-4e9f-9398-5e4b2130c286
Device Description
KM Needle general and hand type is general type its hair-thin shape of stainless steel wire. It has 0.16 ~ 0.70mm body diameter and 15 ~ 135mm body length. All these components are disposable.
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 | 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 | 38800020500084 | GS1 | Master case | 10 | In Commercial Distribution | |
| Package | 28800020500087 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 18800020500080 | GS1 | ||||
| Unit of Use | 08800020500083 | GS1 |
Customer Contacts
- Phone
- +82415587785
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142920 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.25 mm x 60 mm |