FDA UDI
In Commercial Distribution
🇺🇸 United States
Compressed Krinkle Gauze Bandage
DI: 00616784316017
·
Model: 3160
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Compressed Krinkle Gauze Bandage
- Primary DI
- 00616784316017
- Version / Model
- 3160
- 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
- 2026-03-10
- Public Version Status
- Update
- Public Device Record Key
- c4ee8b90-d232-4d25-abe4-140000a4957f
Device Description
Compressed Krinkle Gauze Bandage, Sterile, 4.5"x4.1yd
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
- Yes
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58805 | Absorbent wound compression pad | A rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784316031 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00616784316017 | GS1 |