AccessGUDID - DEVICE: Bard® PTFE Braided Tape (00801741041181)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® PTFE Braided Tape
Version or Model: 007918
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 007918
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741041181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: Bard® PTFE Braided Tape, 4 mm x 91.4 cm

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?
46242	Surgical support tape, non-bioabsorbable	A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 4 Millimeter
Length: 91.4 Centimeter

Device Record Status

Public Device Record Key: 88062438-5c54-4f28-be81-610c9be5052e
Public Version Date: September 10, 2019
Public Version Number: 3
DI Record Publish Date: September 25, 2015