FDA UDI
In Commercial Distribution
🇺🇸 United States
Otological Silicone Strips
DI: EBESSS4506B0
·
Model: SS-4506B
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Otological Silicone Strips
- Primary DI
- EBESSS4506B0
- Version / Model
- SS-4506B
- Catalog Number
- SS-4506B
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 3
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 49ee7c5f-0d31-4417-8e0e-95a30d2f8141
Device Description
Size: 0.12 x 45 x 6 mm; Color: Blue
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47772 | Scar management dressing, single-use, sterile | A sterile covering made of, or coated with, a silicone-based substance (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBESSS4506B0 | HIBCC | ||||
| Package | EBESSS4506B1 | HIBCC | Carton | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 0.12 | Millimeter | |
| Width | 6 | Millimeter | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight