AccessGUDID - DEVICE: Tensoplast® (04042809005769)

GUDID

Device Identifier (DI) Information

Brand Name: Tensoplast®
Version or Model: 02155-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02155-00
Company Name: BSN MEDICAL SAS

Primary DI Number: 04042809005769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 397500849 *Terms of Use

Device Description: TENSOPLAST TAPE 5CMX4.5M STRETCHED TAN 24 USA

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
59015	Pressure bandage, Hevea-latex, single-use	A strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape and bandage, adhesive

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: No
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
Length: 450 Centimeter
Width: 5 Centimeter

Device Record Status

Public Device Record Key: f57996c4-cca5-40c5-9767-69c925f82f63
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04042809005745 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)537-1063
Email: BSN.ORDERS@BSNMEDICAL.COM

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