FDA UDI
In Commercial Distribution
🇺🇸 United States
Butterfly Wound Closures
DI: 00616784361628
·
Model: 3616
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Butterfly Wound Closures
- Primary DI
- 00616784361628
- Version / Model
- 3616
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- ead1a5b5-d5a5-4346-b29b-0a507a91db06
Device Description
Butterfly Wound Closures Sterile with non-stick pad, Large, 1/2"x2 3/4"
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 34865 | Butterfly skin-closure adhesive strip | A small, narrow piece of flexible material covered on one side with a pressure-sensitive adhesive, and with broad, wing-shaped ends that function to approximate the edges of a superficial wound. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784361635 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00616784361628 | GS1 | ||||
| Unit of Use | 00616784361611 | GS1 |