FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemostat Gauze Dressing
DI: 00616784368719
·
Model: 3687
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Hemostat Gauze Dressing
- Primary DI
- 00616784368719
- Version / Model
- 3687
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 3
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- b094628f-8f05-40a9-a1e1-db01cc17e909
Device Description
Hemostat Gauze Dressing, 4"x4"
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
- Yes
- 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 |
|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64869 | Plant polysaccharide/inorganic composite haemostatic agent | A bioabsorbable device consisting of a combination of both: 1) plant polysaccharide-based; and 2) inorganic (i.e., not derived from living matter) synthetic polymer-based [e.g., polyethylene glycol (PEG)] haemostatic agents, intended to be used to achieve haemostasis during an open and/or endoscopic surgical procedure. It is available in various forms (e.g., powder, gel, impregnated gauze); it does not contain an antimicrobial agent. Disposable devices to assist application may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784368726 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00616784368719 | GS1 | ||||
| Package | 00616784368733 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 00616784368740 | GS1 | Shipper | 8 | In Commercial Distribution |