FDA UDI
In Commercial Distribution
🇺🇸 United States
BioGlue Surgical Adhesive
DI: 00877234000263
·
Model: BGDTE-10
·
Artivion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioGlue Surgical Adhesive
- Primary DI
- 00877234000263
- Version / Model
- BGDTE-10
- Catalog Number
- BGDTE-10
- Company Name
- Artivion, Inc.
- Labeler DUNS
- 119253177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 9bf7acf4-229d-47a3-9067-ca1e701e7798
Device Description
BioGlue Surgical Adhesive Delivery Tip Extension
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
- 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
- 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 |
|---|---|---|---|---|
| MUQ | Glue,Surgical,Arteries | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44830 | Open-surgery adhesive/sealant applicator, dual-channel | A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10877234000260 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00877234000263 | GS1 |
Customer Contacts
- Phone
- 770-419-3355
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010003 | 016 |
| P010003 | 017 |
| P010003 | 022 |
| P010003 | 027 |
| P010003 | 028 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius