FDA.reportPublic FDA data

Talymed 10 cm x 10 cm

Primary DI
00389142000193
Brand
Talymed 10 cm x 10 cm
Company
Marine Polymer Technologies, Inc.
Model
400-19
Device description
Talymed 10 cm x 10 cm
Published
2020-08-31
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10389142000190PackageGS15In Commercial Distribution
00389142000193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038914200019010389142000190
00389142000193003891420001933891420001930389142000193

GMDN Terms#

Term, Definition table
TermDefinition
Wound regenerating polysaccharide agentA sterile device consisting primarily of polysaccharides intended to be used to facilitate the regeneration and repair of tissues affected by a chronic wound (e.g., diabetic foot ulcer, venous ulcer, arterial ulcer, pressure ulcer, bedsore) after wound debridement. It may be a solution or sheet containing extracellular matrix regenerating agents (engineered polymers designed to promote wound matrix regeneration) and/or structural elements for native cell attachment/proliferation; devices associated with tissue application/manipulation (e.g., sterile gauze, tweezers) may be included. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
1-888-666-2560pattid@webmpt.com

Regulatory Flags#

DUNS number
809739386
Device count
1
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
00389142000032Syvek Brace with Straps420-052020-10-22
00389142000056SyvekExcel Vascular Access Hemostasis System400-16-05400-16-052016-08-05
00389142000155Syvek Excel Vascular Access Hemostasis Kit400-16-052018-12-17
00389142000001Syvek Radial Band420-02420-022016-08-05
00389142000049Talymed 3 cm x 3 cm 400-352020-08-31
00389142000063Syvek Excel Patch400-162020-01-20
00389142000070Glyko SL Patch 3 cm x 3 cm400-132020-01-20
00389142000087Syvek Patch400-022020-01-20
00389142000094Syvek NT Patch400-092020-01-20
00389142000100Syvek SP Patch400-122020-01-20
00389142000117mrdh bandage 10 cm x 10 cm400-142020-04-09
00389142000124mrdh Bandage 5 cm x 5 cm400-252020-04-09
00389142000131Glyko SL Patch 4 cm x 2 cm400-262020-01-20
00389142000148Glyko SL Patch 4 cm x 4 cm400-242020-01-20
00389142000209Talymed dressing 5 cm x 5 cm400-202020-04-08
00389142000018Syvek Radial Patch400-292020-02-05
10389142000039Syvek Brace with Straps420-052020-10-22
10389142000190Talymed 10 cm x 10 cm400-192020-08-31
10389142000046Talymed 3 cm x 3 cm 400-352020-08-31
10389142000114mrdh bandage 10 cm x 10 cm400-142020-04-09

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