AccessGUDID - DEVICE: Colorado Therapeutics Xenograft Implant (00868623000315)

GUDID

Device Identifier (DI) Information

Brand Name: Colorado Therapeutics Xenograft Implant
Version or Model: XI-S+
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XI0615-S+
Company Name: COLORADO THERAPEUTICS LLC

Primary DI Number: 00868623000315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080356428 *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):	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?
61107	Abdominal hernia surgical mesh, collagen, antimicrobial	A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it includes a pharmaceutical antibacterial agent. It may also be used as a short-term scaffold for tissue regeneration; it is not designed specifically for diaphragmatic hernia repair and has no extra-abdominal applications. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects
FTM	Mesh, Surgical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 40 Degrees Celsius
Storage Environment Temperature: between 35.6 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Centimeter
Height: 6 Centimeter

Device Record Status

Public Device Record Key: 3fa3f75f-5879-4e97-948c-aeb375b7665e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 04, 2017