FDA UDI
In Commercial Distribution
🇺🇸 United States
INTEGRA
DI: 00650551148418
·
Model: 3612-11L-I-ST
·
PMT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTEGRA
- Primary DI
- 00650551148418
- Version / Model
- 3612-11L-I-ST
- Company Name
- PMT CORPORATION
- Labeler DUNS
- 039576871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-17
- Public Version
- 1
- Public Version Date
- 2020-08-25
- Public Version Status
- New
- Public Device Record Key
- de1cd828-6a6b-4217-a3c8-aa928997dcd0
Device Description
INTEGRA BE CRESCENT SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00650551148418 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K845036 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 150 | Milliliter | |
| Length | 7.6 | Centimeter | |
| Width | 11 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 58 – 78 Degrees Fahrenheit