FDA UDI
In Commercial Distribution
🇺🇸 United States
AART Silicone Sheeting
DI: B4902013340B1
·
Model: B
·
Aart
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- AART Silicone Sheeting
- Primary DI
- B4902013340B1
- Version / Model
- B
- Catalog Number
- 201-33-40B
- Company Name
- Aart
- Labeler DUNS
- 091356894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-12-20
- Public Version
- 4
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- aecca899-2c2c-4464-ac0c-c1d021900116
Device Description
Silicone Sheeting, 3"x3"x.040 R Sterile
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
- No
- 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
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MIB | ELASTOMER, SILICONE BLOCK | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61557 | Silicone-sheet tissue reconstructive material | A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B4902013340B1 | HIBCC | ||||
| Unit of Use | B4902013340B0 | HIBCC |
Customer Contacts
- Phone
- +1(775)853-6800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022223 | 000 |