AccessGUDID - DEVICE: Biodesign (00827002542020)

GUDID

Device Identifier (DI) Information

Brand Name: Biodesign
Version or Model: G54202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-FP-0.7
Company Name: COOK BIOTECH INCORPORATED

Primary DI Number: 00827002542020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945385862 *Terms of Use

Device Description: Biodesign Fistula Plug

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?
62447	Fistula-repair biomatrix implant	A bioabsorbable, animal-derived substance intended to be implanted into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue. It consists primarily of an animal-derived matrix structure (e.g., made of collagen) that provides a scaffold for cell migration and growth, and which is gradually incorporated into and remodelled by host tissue. The material is typically preloaded in a disposable syringe.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062729	000
K170016	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 a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d12dcec-f696-41f6-af77-327b9707d7f9
Public Version Date: February 19, 2025
Public Version Number: 3
DI Record Publish Date: March 27, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10827002542027	1	00827002542020		In Commercial Distribution	BX

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: +1(812)330-5494
Email: sharedservices@cookmedical.com

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