FDA UDI
In Commercial Distribution
🇺🇸 United States
HowSport
DI: 06975380612003
·
Model: SB6-50/4.5-ZCM(BK)
·
JIAXING HOW SPORT MEDICAL INSTRUMENT CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- HowSport
- Primary DI
- 06975380612003
- Version / Model
- SB6-50/4.5-ZCM(BK)
- Company Name
- JIAXING HOW SPORT MEDICAL INSTRUMENT CO., LTD.
- Labeler DUNS
- 548230575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-26
- Public Version
- 1
- Public Version Date
- 2023-05-04
- Public Version Status
- New
- Public Device Record Key
- d2b7eada-2924-4bca-bc63-374dd10a7795
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58986 | Multi-purpose surgical skin adhesive tape | A long thin band of synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 56975380612008 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 06975380612003 | GS1 | ||||
| Package | 16975380612000 | GS1 | 6 | In Commercial Distribution | ||
| Package | 26975380612007 | GS1 | 144 | In Commercial Distribution |