FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-XC™ Plug
DI: 10841307123705
·
Model: BIO-XCP
·
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bio-XC™ Plug
- Primary DI
- 10841307123705
- Version / Model
- BIO-XCP
- Catalog Number
- BIO-XCP
- Company Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Labeler DUNS
- 868856969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-26
- Public Version
- 2
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- b2bb5490-dd33-489f-9cd2-ffefb51e3d51
Device Description
Bio-XC™ Plug Resorbable Collagen - 10mm x 20mm
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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47184 | General oral wound dressing, animal-derived | A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20841307123702 | GS1 | Chipboard Carton | 10 | In Commercial Distribution | |
| Primary | 10841307123705 | GS1 |
Customer Contacts
- Phone
- 1-888-649-6425
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Width: 10mm Length: 20mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit