FDA.reportPublic FDA data

Redicare

Primary DI
B70901040252
Brand
Redicare
Company
REDICARE LLC
Model
Sterile Pads 3" x 3"
Catalog number
0104025
Device description
10 Sterile Gauze Pads 3x3 inch 10/box
Published
2020-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B70901040252PackageHIBCC48In Commercial Distribution
B70901040251PrimaryHIBCC0
B70901040250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8665615650info@redicaredirect.com

Regulatory Flags#

DUNS number
800149346
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B70901070010Redicare"Instant Ice Pack 4"" x 5"""01070012020-07-28
B70901070040Redicare"Instant Ice Pack 5"" x 8"""01070042020-07-28
B70901040251Redicare"Sterile Pads 3"" x 3"""01040252020-07-28
B70901040341Redicare"Non Adherent Pad 2"" x 3"""01040342020-07-28
B70901020180RedicareResuscitation Kit01020182020-07-28
B70901020760RedicareResuscitation Kit01020762020-07-28
B70901130700RedicareArterial Tourniquet with Windlass01130702022-04-28
B70903030130RedigloveNitrile Examination Glove03030132022-04-28
B70903030131RedigloveNitrile Examination Glove03030132022-04-28
B70901140070Redicare"Burn Gel Dressing 4"" x 4"""01140072020-07-28
B70901140080Redicare"Burn Gel Dressing 4"" x 4"""01140082020-08-25
B70901140081RedicareBurn Gel Dressing 4" x 4"01140082020-08-25
B70901030021RedicarePlastic Bandages Wide Strips01030022020-07-28
B70901030041RedicareFabric Wide Strip Bandage01030042020-07-28
B70901030071RedicareFabric Knuckle Bandage01030072020-07-28
B70901030131RedicareFingertip XL Fabric Bandage01030132020-07-28
B70901030161RedicareLarge Patch Fabric Bandages01030162020-07-28
B70901030171RedicareSuper Large Patch Fabric Bandages01030172020-07-28
B70901030221RedicareJunior Strip Fabric Bandages01030222020-07-28
B70901040100RedicareCohesive Flex Bandage01040102020-07-28

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Primary DI, Brand, Company table
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