FDA UDI
In Commercial Distribution
🇺🇸 United States
Biodesign
DI: 00827002602854
·
Model: G60285
·
COOK BIOTECH INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Biodesign
- Primary DI
- 00827002602854
- Version / Model
- G60285
- Catalog Number
- ENT-OTO-BFLY-0.4-0.6
- Company Name
- COOK BIOTECH INCORPORATED
- Labeler DUNS
- 945385862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 3
- Public Version Date
- 2025-02-19
- Public Version Status
- Update
- Public Device Record Key
- 0106ccbc-8f33-4a0a-8eaf-b651b7e02984
Device Description
Biodesign Otologic Butterfly Graft
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
- MR Safe
- 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 |
|---|---|---|---|---|
| KHJ | POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64915 | ENT tissue biomatrix implant | A bioabsorbable, animal-derived material intended to be surgically implanted to serve as a scaffold for soft tissue regeneration primarily in ear/nose/throat (ENT) procedures, typically in tympanum (eardrum) and/or nasal septum reconstruction; it may in addition be used as a membrane barrier to prevent undesired soft-tissue penetration into space intended for healing bone. It is available in a variety of sizes and shapes and consists primarily of an animal-derived matrix structure (e.g., equine collagen) which is gradually absorbed and replaced by host tissue. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10827002602851 | GS1 | BX | 1 | In Commercial Distribution | |
| Primary | 00827002602854 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232646 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.