FDA.reportPublic FDA data

Medicom

Primary DI
10686864060779
Brand
Medicom
Company
AMD Medicom Inc
Model
4900-STAT
Catalog number
4900-STAT
Device description
"Medicom HemoStat - Topical Sterile Dressing - 4 Ply - White 0.75"" x 0.75"" "
Published
2024-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173196000SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd.2018-01-24OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864060776PackageGS1200In Commercial Distribution
10686864060779PrimaryGS10
00686864060772Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686406077620686864060776
1068686406077910686864060779
00686864060772006868640607726868640607720686864060772

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. 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, Specify00Between 5°C and 40°C (i.e. between 41°F and 104°F)

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
20
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061998Ocean Pacific NeoNatural1229-B1229-B2026-06-29
10686864062001Ocean Pacific NeoNatural1229-C1229-C2026-06-29
10686864062018Ocean Pacific NeoNatural1229-D1229-D2026-06-29
10686864062032Ocean Pacific NeoNatural1229B-SP61229B-SP62026-06-29
10686864062049Ocean Pacific NeoNatural1229C-SP61229C-SP62026-06-29
10686864062056Ocean Pacific NeoNatural1229D-SP61229D-SP62026-06-29
10686864016110Medicom AssureTouch9998-E9998-E2022-09-28
10686864029110Medicom AssureTouch9999-A9999-A2022-09-28
10686864048876AMD-RITMED SOLON55900559002023-07-10
10686864053955Medicom AssureTouch9950-C9950-C2022-09-28
10686864053962Medicom AssureTouch9950-D9950-D2022-09-28
10686864053979Medicom AssureTouch9950-E9950-E2022-09-28
10686864053986Medicom AssureTouch9950-F9950-F2022-09-28
10686864055058Medicom AssureTouch9950-B9950-B2022-09-28
10686864060113Medicom AssureTouch9985-A9985-A2023-07-27
10686864060120Medicom AssureTouch9985-B9985-B2023-07-27
10686864060137Medicom AssureTouch9985-C9985-C2023-07-27
10686864060144Medicom AssureTouch9985-D9985-D2023-07-27
10686864060151Medicom AssureTouch9985-E9985-E2023-07-27
20686864021661AMD-RITMED5100-B5100-B2019-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
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04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
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04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
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04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
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04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213606Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213590Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850467Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213132Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213170Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213477HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213484HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
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04714691850290HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
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