AccessGUDID - DEVICE: Zenapro (10827002354798)

GUDID

Device Identifier (DI) Information

Brand Name: Zenapro
Version or Model: G35479
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-HYB-20X20
Company Name: COOK BIOTECH INCORPORATED

Primary DI Number: 10827002354798
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 945385862 *Terms of Use

Device Description: Zenapro Hybrid Hernia Repair 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?
61545	Extra-gynaecological surgical mesh, biologic-polymer composite	A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, surgical, polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111695	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
Special Storage Condition, Specify: Store in clean, dry location at room temperature
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9399f6b5-13f3-4f87-99ca-9b450bb40a5d
Public Version Date: February 19, 2025
Public Version Number: 7
DI Record Publish Date: November 03, 2015