AccessGUDID - DEVICE: Biodesign (00827002542525)

GUDID

Device Identifier (DI) Information

Brand Name: Biodesign
Version or Model: G54252
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-SLRA-OPEN-GIA80
Company Name: COOK BIOTECH INCORPORATED

Primary DI Number: 00827002542525
Issuing Agency: GS1
Commercial Distribution End Date: July 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 945385862 *Terms of Use

Device Description: Biodesign Staple Line Reinforcement

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
47818	Staple line-reinforcement strip	A sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OXE	Mesh, surgical, collagen, staple line reinforcement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070405	000
K170945	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: e1714825-f386-4d1b-bd21-e92a70f471aa
Public Version Date: February 19, 2025
Public Version Number: 5
DI Record Publish Date: November 03, 2015