FDA.reportPublic FDA data

XCelliStem

Primary DI
00864567000336
Brand
XCelliStem
Company
STEMSYS LLC
Model
XSWP0500
Device description
Wound Powder, 500mg
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172593000XCelliStem Wound PowderStemsys2018-03-16KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864567000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864567000336008645670003368645670003360864567000336

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080053326
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08600103725002ReyaGelRG032026-02-02
00864567000312XCelliStemXSWP02502018-08-15
00864567000329XCelliStemXSWP10002018-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632670OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632700OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632755OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02