AccessGUDID - DEVICE: FatSilk (00851314007380)

GUDID

Device Identifier (DI) Information

Brand Name: FatSilk
Version or Model: 19-7500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Innovative Med

Primary DI Number: 00851314007380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928308407 *Terms of Use

Device Description: Diamond Filter

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?
62059	Suction system filter, tissue, sterile	A sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic/therapeutic purposes (e.g., autologous fat tissue transfer, histological/pathological analysis). It is a meshed flat or tubular piece; accessory components (e.g., container sealing rings, tubing, filter housing) may be included. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KET	Filters, Cell Collection, Tissue Processing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 78934733-74a2-404d-83ca-35438222d47a
Public Version Date: July 04, 2019
Public Version Number: 1
DI Record Publish Date: June 26, 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

[?]

Phone: 949-458-1897
Email: benk@imibeauty.com

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