AccessGUDID - DEVICE: Cellfina System Disposable Procedure Kit (00840763100827)

GUDID

Device Identifier (DI) Information

Brand Name: Cellfina System Disposable Procedure Kit
Version or Model: Rev O
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CK1
Company Name: Ulthera, Inc.

Primary DI Number: 00840763100827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010981554 *Terms of Use

Device Description: No description.

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):	No
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?
62248	Mechanical skin contouring system injection/transection set	A collection of sterile components of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It consists of template plates, needle and microblade assemblies to guide instruments, and a vacuum-assisted capture unit to control the tissue being treated. The device is placed on the skin, an area of skin/subcutaneous tissue is drawn by suction into a dome, and local anaesthesia is infiltrated prior to subcutaneous transection by a motorized cutting tool. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161885	000

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: 21324312-25a5-430f-8a1d-d6e696fce20d
Public Version Date: May 09, 2024
Public Version Number: 2
DI Record Publish Date: March 18, 2019

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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