FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Dermal Regeneration Template
DI: 10381780000556
·
Model: 32025
·
Integra Lifesciences Corporation
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Integra® Dermal Regeneration Template
- Primary DI
- 10381780000556
- Version / Model
- 32025
- Catalog Number
- 32025
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2014-09-05
- Public Version
- 6
- Public Version Date
- 2021-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0ee0af89-adc7-46c2-a5b0-8312bbed1097
Device Description
INTEGRA Dermal Regeneration Template 2in. x 2in. (5cm x 5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGR | Dressing, Wound And Burn, Interactive | Unknown | 3 | |
| MDD | Device, dermal replacement | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Collagen wound matrix dressing | A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M269320251 | HIBCC | ||||
| Primary | 10381780000556 | GS1 | ||||
| Unit of Use | 00381780000559 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900033 | 011 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 in x 2 in |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Flat
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius