AccessGUDID - DEVICE: POLYESTER TAPE (00384401513070)

GUDID

Device Identifier (DI) Information

Brand Name: POLYESTER TAPE
Version or Model: Size 6.4mm x 45.7 cm (1/4 in x 18 in)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTERVASCULAR SAS

Primary DI Number: 00384401513070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 382174019 *Terms of Use

Device Description: Polyester Tape size 6.4mm x 45.7 cm (1/4 in x 18 in) are commercially available only in multipack configuration (1 pair per pouch / 5 pouches per box) with the catalog number M002000194211.

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":	Yes
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
DWS	Instruments, Surgical, Cardiovascular

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
Special Storage Condition, Specify: Store at controlled room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac99813e-728c-445e-a750-f4853256315b
Public Version Date: September 10, 2019
Public Version Number: 3
DI Record Publish Date: May 16, 2017