AccessGUDID - DEVICE: AVID TruCustom (10809160036679)

GUDID

Device Identifier (DI) Information

Brand Name: AVID TruCustom
Version or Model: YNHN044-01_0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVID MEDICAL, INC.

Primary DI Number: 10809160036679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015623119 *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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
47933	Skin allograft	Skin tissue intended for transplantation that is harvested from a human donor genetically different from the human recipient. The implanted tissue is intended to repair, replace, or reinforce skin affected by extensive wounds, burns, and soft tissue defects and typically helps to protect against infection, reduce pain, reduce fluid loss, and/or allows the native tissues underneath to heal. It is typically cryopreserved cadaver skin from a skin bank which may have been subjected to various degrees of processing (e.g., epidermis removal, decellularized dermis, glycerolization, sterilization). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LRO	General surgery tray

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 13988784-efb9-4085-ac69-8c343f09dc1d
Public Version Date: September 12, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20809160036676	10	10809160036679		In Commercial Distribution

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: Yes
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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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