AccessGUDID - DEVICE: Epicel (cultured epidermal autografts) (W41020AU201S1969)

GUDID

Device Identifier (DI) Information

Brand Name: Epicel (cultured epidermal autografts)
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VERICEL CORPORATION

Primary DI Number: W41020AU201S1969
Issuing Agency: ICCBBA
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079745570 *Terms of Use

Device Description: Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61662	Cultured skin autograft/xenograft	A non-sterile tissue, in vitro cultivated from cells of human and animal origin, intended to cover skin wounds typically resulting from a burn injury. It is developed by ex vivo aseptic processing of a biopsy of skin from the recipient, involving enzymatic digestion and multiplication (culture) of epidermal cells combined with proliferation-arrested, murine (mouse) fibroblasts, to produce a graft of sufficient size for wound coverage. It is typically supplied by attachment to a gauze backing and may be used alone or in conjunction with split-thickness skin autografts.	Active	true

FDA Product Code

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Product Code	Product Code Name
OCE	Cultured Epithelial Autograft

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BH990200	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 13 and 23 Degrees Celsius
Storage Environment Temperature: between 55 and 73 Degrees Fahrenheit
Special Storage Condition, Specify: Inspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged.
Special Storage Condition, Specify: Store Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use.
Special Storage Condition, Specify: Keep Epicel out of the operating room until ready for application
Special Storage Condition, Specify: Inspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy, or the graft dish has a broken seal or appears cloudy..
Special Storage Condition, Specify: Maintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F).
Special Storage Condition, Specify: Do not store in a refrigerator or freezer. Do not refrigerate, freeze, or incubate the Epicel shipping container or its contents. Do not reuse, freeze, refrigerate, or sterilize Epicel after opening.
Special Storage Condition, Specify: Inspect the self-seal bags that contain Epicel grafts for media leaks. If a self-seal bag contains media, then inspect each graft dish in the bag for broken seal or damage prior to use.

Clinically Relevant Size

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Size Type Text
Area/Surface Area: 50 Square centimeter

Device Record Status

Public Device Record Key: e062635a-2a0e-4797-a134-4300dec9b2ab
Public Version Date: February 13, 2024
Public Version Number: 1
DI Record Publish Date: February 05, 2024