FDA UDI
In Commercial Distribution
🇺🇸 United States
Kaydee
DI: 06947084923150
·
Model: SSK-15H
·
Xi'an Kaydee Medical Appliances Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Kaydee
- Primary DI
- 06947084923150
- Version / Model
- SSK-15H
- Company Name
- Xi'an Kaydee Medical Appliances Co.,Ltd
- Labeler DUNS
- 529128708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 2
- Public Version Date
- 2022-12-14
- Public Version Status
- Update
- Public Device Record Key
- ff69fe55-ad4e-4778-842d-b0d939a95793
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QQS | Stapler, Skin | General Hospital | 878.4740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35884 | Skin stapler/staple, non-bioabsorbable | A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06947084923150 | GS1 | ||||
| Package | 16947084923157 | GS1 | Medium packaging | 10 | In Commercial Distribution | |
| Package | 26947084923154 | GS1 | Medium packaging | 6 | In Commercial Distribution | |
| Package | 56947084923155 | GS1 | Outer packaging | 80 | In Commercial Distribution | |
| Package | 66947084923152 | GS1 | Outer packaging | 72 | In Commercial Distribution |