FDA.report

TIGER MEDICAL COHESIVE BANDAGE

Primary DI
10840216100012
Brand
TIGER MEDICAL COHESIVE BANDAGE
Company
Asp Global, LLC
Model
BCT209
Device description
COHESIVE BANDAGE 25.4MM X 4.57M(1" X 5YDS) LATEX FREE, NON-STERILE, TAN
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ITGBandage, Cast

Product Code Classifications

CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840216100012PackageGS16In Commercial Distribution
20840216100019PackageGS130In Commercial Distribution
00840216100015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084021610001210840216100012
2084021610001920840216100019
00840216100015008402161000158402161000150840216100015

GMDN Terms

TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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50192253045879WebrilCardinal Health 200, LLCITG2025-09-23
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50192253045923WebrilCardinal Health 200, LLCITG2025-09-23
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07290100665619Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665626Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665633Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665640Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
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00810180842112CurPro Undercast Padding, 100% Polyester, 6" x 4 yd Dynarex CorporationITG2025-06-05
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20192253045755CurityCardinal Health 200, LLCITG2025-03-19
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50885632106512MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50885632106536MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50197106823017CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
06430053260238WOODCASTDassiet OyITG2024-08-11
06430053260252WOODCASTDassiet OyITG2024-08-11
06430053265837WOODCASTDassiet OyITG2024-08-11