FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard® DeBakey® Elastic Knit Fabric
DI: 00801741041075
·
Model: 007831
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bard® DeBakey® Elastic Knit Fabric
- Primary DI
- 00801741041075
- Version / Model
- 007831
- Catalog Number
- 007831
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-25
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 839da582-b843-4284-a309-a4196c4d984c
Device Description
Bard® DeBakey® Elastic Knitted Polyester Fabric, 15.2 cm x 15.2 cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | Cardiovascular | 870.3470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31744 | Cardiovascular patch, synthetic | An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741041072 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741041075 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 15.2 | Centimeter | |
| Length | 15.2 | Centimeter |