CURCO
- Primary DI
- 00850084084058
- Brand
- CURCO
- Company
- FR TECH, LLC
- Model
- FR1014
- Device description
- Collagen Sheet 1" x 4"
- Published
- 2026-06-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | Unknown | U |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K122325 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850084084055 | Package | GS1 | 10 | In Commercial Distribution |
| 00850084084058 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850084084055 | 10850084084055 | ||
| 00850084084058 | 00850084084058 | 850084084058 | 0850084084058 |
GMDN Terms#
| Term | Definition |
|---|---|
| Animal-derived wound matrix dressing | A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 142168435
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850084084010 | CURCO | FR1011 | 2026-06-02 | |
| 00850084084027 | CURCO | FR1022 | 2026-06-02 | |
| 00850084084034 | CURCO | FR1044 | 2026-06-02 | |
| 00850084084041 | CURCO | FR1077 | 2026-06-02 | |
| 00850084084065 | CURCO | FR1110 | 2026-06-02 | |
| 00850084084072 | CURCO | FR1210 | 2026-06-02 | |
| 00850084084089 | CURCO | FR1000 | 2026-06-02 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00810179632403 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632410 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632427 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632434 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632441 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632458 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632465 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632472 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632595 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632601 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632618 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632625 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632632 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632649 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632656 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632663 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632670 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632687 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632694 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632700 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632717 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632724 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632731 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632748 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632755 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 00810179632762 | OASIS | COOK BIOTECH INCORPORATED | KGN | 2026-07-31 |
| 09421908222515 | Myriad Meshed Soft Tissue Bioscaffold | AROA BIOSURGERY LIMITED | KGN | 2026-07-04 |
| 00860012016686 | MaxioCel Chitosan Wound Dressing | Advamedica Inc. | KGN | 2026-06-08 |
| 00850084084010 | CURCO | FR TECH, LLC | KGN | 2026-06-02 |
| 00850084084027 | CURCO | FR TECH, LLC | KGN | 2026-06-02 |