FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AlloX Remote Port Tissue Expander Accessories
DI: M746ARPA010
·
Model: ARPA01
·
SPECIALTY SURGICAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AlloX Remote Port Tissue Expander Accessories
- Primary DI
- M746ARPA010
- Version / Model
- ARPA01
- Catalog Number
- ARPA01
- Company Name
- SPECIALTY SURGICAL PRODUCTS INC
- Labeler DUNS
- 002112626
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-15
- Public Version
- 4
- Public Version Date
- 2019-09-23
- Public Version Status
- Update
- Public Device Record Key
- 522c8909-adc7-4111-b05a-09637e66b72b
- Distribution End Date
- 2016-11-11
Device Description
AlloX Remote Port Tissue Expander Accessories, For Use with SSP AlloX Remote Drain Port Tissue Expanders
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCJ | Expander, Skin, Inflatable | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45187 | Skin-port tissue expander | An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M746ARPA010 | HIBCC |
Customer Contacts
- Phone
- 888-878-0811
- [email protected]