Identity
- Trade Name
- INTEGRA® FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- TE HORSESHOE, 2.5 X 7.5CM, 2.9CM PROJECTION, 100CC FILL, MICRO TUBING FDA UDI
- Model / Reference
- 3614-556 FDA UDI
- Description
- TE HORSESHOE, 2.5 X 7.5CM, 2.9CM PROJECTION, 100CC FILL, MICRO TUBING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551004318 FDA UDI
- 510(k) Number
- K845036 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Skin-port tissue expander FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin-port tissue expander
Integra® by Pmt Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-port tissue expander.
- MENTOR CPX 4 Breast Tissue Expander — Mentor Texas LP · U
- Dermaspan Tissue Expander — Sientra, Inc. · U
- Softspan Tissue Expander — Sientra, Inc. · U
- Natrelle 133S Tissue Expanders — Allergan · U
- Flora™ Tissue Expander SMOOTHSILK® — Establishment Labs S.A. · U
- Softspan Tissue Expander — Sientra, Inc. · U
- AlloX2 Tissue Expander — Sientra, Inc. · U
- Softspan Tissue Expander — Sientra, Inc. · U
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Pmt Corp.
Sources (1)
- FDA UDI 2900516c-5335-4bce-8600-8ffe51ad06ac 34 fields · synced May 31, 2026