DEVICE: VACSURE Uni-Band (00850014448134)

Device Identifier (DI) Information

VACSURE Uni-Band
RR-151
In Commercial Distribution

LABOTEK GROUP CORP
00850014448134
GS1

100
117338398 *Terms of Use
VACSURE Uni-Band, Universal bandage, 28 x 15 mm pad size, 19 x 38 mm overall size, Individually wrapped
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34864 Adhesive bandage
A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGX Tape And Bandage, Adhesive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 28 Millimeter
Width: 15 Millimeter
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Device Record Status

85584b7f-4f7a-463f-a1b1-605ffe10d548
March 26, 2024
1
March 18, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00850014448141 100 00850014448134 In Commercial Distribution Box
10850014448148 60 00850014448141 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 10850014448131 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
7877851555
e.colon@labotekgroup.com
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