FDA.reportPublic FDA data

MEDICOM

Primary DI
20686864048552
Brand
MEDICOM
Company
AMD Medicom Inc
Model
4554
Catalog number
4554
Device description
MEDICOM COTTON DENTAL ROLL 1 1/2 X 3/8 Inch
Published
2019-01-16
Public version status
Update
Distribution status
Not 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
EFNCOTTON, ROLL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864048552PackageGS112Not in Commercial Distribution
10686864048555PrimaryGS10
00686864048558Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404855220686864048552
1068686404855510686864048555
00686864048558006868640485586868640485580686864048558

GMDN Terms#

Term, Definition table
TermDefinition
Dental cotton rollA non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
2000
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194401657AiraAIRA, LLCEFN2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
50732224001086Ultra Gauze Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2025-10-23
00810124531843Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-09-03
00810132808203House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
00810132044281HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
00810132044274HCSConcordance Healthcare Solutions LLCEFN2025-03-05
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701991Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184810Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10850053289535SURGYCOSurgyco LLCEFN2024-08-09
10850053289542SURGYCOSurgyco LLCEFN2024-08-09
00850053289538SURGYCOSurgyco LLCEFN2024-08-09