AccessGUDID - DEVICE: RECELL (00851707004149)

GUDID

Device Identifier (DI) Information

Brand Name: RECELL
Version or Model: US 1920
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C3RL01-B:US
Company Name: AVITA MEDICAL AMERICAS, LLC

Primary DI Number: 00851707004149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026723570 *Terms of Use

Device Description: RECELL Autologous Cell Harvesting Device

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58417	Autologous skin cell grafting kit	A collection of sterile devices designed to disaggregate cells from a split-thickness skin biopsy for immediate application to a prepared wound bed in the donor patient (skin cell autograft) to promote healing and skin cover. It typically includes a processing unit with battery-powered heater, a disassociation enzyme, a buffer solution, a spray delivery applicator, and various syringes and needles. The donor skin is prepared with heated enzyme and then scraped to create a suspension of mixed skin cell types in the buffer solution which is typically applied to the recipient site by spray or droplet. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QCZ	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP170122	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 342a3555-a0fa-476d-9aba-492f5bf9f1f2
Public Version Date: November 26, 2018
Public Version Number: 1
DI Record Publish Date: October 26, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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