Device
SurCura Wound Matrix is a sterile,single-use device intended for use in the management of wounds.
Manufacturer
Beijing Kreate Medical Co., Ltd.
Beijing Kreate Medical Co., Ltd.
Model: SCWM-55D
DI: 06977727072815
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
SurCura Wound Matrix is a sterile,single-use device intended for use in the management of wounds.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8bcac7d5-95de-4c24-9267-62151af6380a
Distribution Status:
In Commercial Distribution
DUNS Number:
843094168
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06977727072815
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64853
Name: Synthetic wound matrix dressing
Definition:
A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.
FDA Product Codes
QSZ
Absorbable Synthetic Wound Dressing
Premarket Submissions
Submission Number:
K260020
Supplement Number:
000