FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoClot
DI: 16972011720011
·
Model: EPK2302-01
·
EndoClot Plus Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EndoClot
- Primary DI
- 16972011720011
- Version / Model
- EPK2302-01
- Company Name
- EndoClot Plus Co.,Ltd.
- Labeler DUNS
- 544357082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-15
- Public Version
- 1
- Public Version Date
- 2022-03-23
- Public Version Status
- New
- Public Device Record Key
- 572be470-df59-4bec-8bdf-01b1b1c017c9
Device Description
EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | General, Plastic Surgery | 878.4456 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38771 | Plant polysaccharide haemostatic agent, bioabsorbable | A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26972011720018 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 16972011720011 | GS1 | ||||
| Package | 36972011720015 | GS1 | 14 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190677 | 000 |