FDA.reportPublic FDA data

Syvek Excel Patch

Primary DI
00389142000063
Brand
Syvek Excel Patch
Company
Marine Polymer Technologies, Inc.
Model
400-16
Device description
Syvek Excel Patch
Published
2020-01-20
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
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20389142000067PackageGS120In Commercial Distribution
00389142000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038914200006720389142000067
00389142000063003891420000633891420000630389142000063

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.

Contacts#

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

Regulatory Flags#

DUNS number
809739386
Device count
1
Premarket exempt
true
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
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
00389142000193Talymed 10 cm x 10 cm400-192020-08-31
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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Primary DI, Brand, Company table
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00197998367281Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367359Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367427Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998152252Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152344Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152375Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305801Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305832Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305863Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305894Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305924Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305955Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415500Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415548Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415586Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415623Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998418976Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419010Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419058Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419829Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
06948909462250GentellShaoxing Haoshide Medical Products Co., Ltd.NAC2026-08-21
06940610127725VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127787VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127848VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14