FDA.reportPublic FDA data

AMD-RITMED

Primary DI
20686864043205
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
55992C
Catalog number
55992C
Device description
AMD-RITMED NEURO SPONGE SINGLE STRUNG X-R DETECTABLE 1/2 X 1/2 Inch
Published
2019-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGauze/Sponge, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830269000FLORET NEURO SPONGERitmed, Inc.1983-06-02EFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864043205PrimaryGS10
00686864043201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404320520686864043205
00686864043201006868640432016868640432010686864043201

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque non-woven surgical spongeA non-medicated device made from a non-woven absorbent material (e.g., rayon/polyester) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It is intended to produce less lint than woven gauze and contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262mdasilva@medicom.ca
+1(514)636-6262FURLS@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864044434AMD-RITMED85992C85992C2019-01-15
10686864044441AMD-RITMED85993C85993C2019-01-15
10686864044458AMD-RITMED85994C85994C2019-01-15
10686864044465AMD-RITMED85995C85995C2019-01-15
10686864044472AMD-RITMED85996C85996C2019-01-15
10686864044489AMD-RITMED85997C85997C2019-01-15
10686864044496AMD-RITMED85998C85998C2019-01-15
20686864043212AMD-RITMED55993C55993C2019-01-15
20686864043229AMD-RITMED55994C55994C2019-01-15
20686864043236AMD-RITMED55995C55995C2019-01-15
20686864043243AMD-RITMED55996C55996C2019-01-15
20686864043250AMD-RITMED55997C55997C2019-01-15
20686864043267AMD-RITMED55998C55998C2019-01-15
10686864061950Ocean Pacific NeoNatural1228B-SP101228B-SP102026-07-13
10686864061967Ocean Pacific NeoNatural1228C-SP101228C-SP102026-07-13
10686864061974Ocean Pacific NeoNatural1228D-SP101228D-SP102026-07-13
10686864061868MEDICOM SAFESEAL76112761122026-06-25
10686864061875MEDICOM SAFESEAL76115761152026-06-25
10686864061899MEDICOM SAFESEAL76020760202026-06-25
10686864061905MEDICOM SAFESEAL76024760242026-06-25

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10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
00843471152782DefendYoung Innovations, Inc.EFQ2022-10-30
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00683534830178A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830185A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830277A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830284A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19