FDA.reportPublic FDA data

STRADIS

Primary DI
M7528204041
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
820-404
Device description
STERILE SEPARATE-GAUZE 4X4
Published
2017-02-01
Public version status
Update
Distribution status
Not 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
MGPDressing, Wound And Burn, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7528204041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525250271STRADIS525-027525-0272016-05-04
M7525250291STRADIS525-029525-0292016-05-04
M752525021R11STRADIS525-0212016-09-10
M752525027R11STRADIS525-0272016-09-10
M752525028R11STRADIS525-0282016-09-17
M752525029R11STRADIS525-0292016-09-17
M752525037R11STRADIS525-0372016-09-17
M752525038R10Stradis Medical, LLC.525-038 R12017-04-12
M752525038R11STRADIS525-0382016-09-10
M752525038SAR11STRADIS525-038SA2016-09-10
M752525065R11STRADIS525-0652016-09-10
M752525072R11STRADIS525-0722016-09-10
M7525250791STRADIS525-079525-0792016-05-04
M752525079R11STRADIS525-0792016-09-10
M752525083R11STRADIS525-0832016-09-10
M7525251551STRADIS525-1552016-09-17
M752525202R11STRADIS525-2022016-09-10
M752525462R11STRADIS525-4622016-09-10
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704738066RUSCHTELEFLEX INCORPORATEDMGP2026-08-01
30884389803114MEDLINEMEDLINE INDUSTRIES, INC.MGP2024-08-06
00810050460033Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460101Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460118Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
10810050460030Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460108Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460115Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
00810050460019Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
00810050460026Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
00810050460040Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
00810050460057Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
10810050460016Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
10810050460023Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
10810050460047Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
10810050460054Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
00050428287071CVS Health™WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMGP2022-09-24
M7528900120Stradis Medical, LLC.STRADIS MEDICAL, LLCMGP2022-06-01
M7528900030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528900031STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528910030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528204040STRADIS STRADIS MEDICAL, LLCMGP2022-05-16
M7528900070STRADIS HEALTHCARESTRADIS MEDICAL, LLCMGP2022-03-31
00856525007365PFAB SMALLSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007372PFAB MediumSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007389PFAB Medium CrescentSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007396PFAB LargeSUN SCIENTIFIC, INC.MGP2021-04-30
05000223449889"ACTICOAT 4""X48"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565121536ACTICOAT 4"X48"SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565122045"ACTICOAT 3 5"" X 5"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16