FDA.report

Opsite Post-Op Visible 30x10cm Ctn 20

Primary DI
05000223468682
Brand
Opsite Post-Op Visible 30x10cm Ctn 20
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66800140
Catalog number
66800140
Device description
Waterproof, bacteria proof dressing with absorbent see through pad
Published
2020-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05000223468682PackageGS120In Commercial Distribution
05000223468743PackageGS16In Commercial Distribution
05000223468620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05000223468682050002234686825000223468682
05000223468743050002234687435000223468743
05000223468620050002234686205000223468620

GMDN Terms

TermDefinition
Adhesive bandageA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05000223499389RENASYS66803107668031072025-09-23
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05000223499402RENASYS66803105668031052025-09-23
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05000223504274RENASYS66807736668077362025-09-23
05000223504281RENASYS66807735668077352025-09-23
05000223501686ALLEVYN™ Ag+66027663660276632025-08-12
05000223501693ALLEVYN™ Ag+66027664660276642025-08-12
05000223501709ALLEVYN™ Ag+66027665660276652025-08-12
05000223501808ALLEVYN™ Ag+66027669660276692025-08-12
05000223501815ALLEVYN™ Ag+66027670660276702025-08-12
05000223503178ALLEVYN COMPLETE CARE66807697668076972025-07-30

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