FDA.reportPublic FDA data

Surgaflex

Primary DI
00850019162288
Brand
Surgaflex
Company
IMBED BIOSCIENCES, INC.
Model
91017
Device description
Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5.
Published
2025-02-24
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153756000Microlyte AgImbed Biosciences, Inc.2016-08-04FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019162288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019162288008500191622888500191622880850019162288

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag)]. It is intended to protect and facilitate healing of minor cuts, scrapes, abrasions, lacerations, blisters, and scalds by absorbing wound exudates while creating a moist wound-healing environment and reducing microbial colonization within the dressing. The device is typically in the form of a flat sheet/film and is intended for use in the home or a clinical setting. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-472-9898cs@imbedbio.com

Regulatory Flags#

DUNS number
962084500
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019162424Microlyte MatrixML06082026-04-15
00850019162363Microlyte PainGuardMLPG03032025-08-21
00850019162370Microlyte PainGuardMLPG05052025-08-21
00850019162387Microlyte PainGuardMLPG10102025-08-21
00850019162394Pelashield PainGuardPSPG10232025-08-21
00850019162400Pelashield PainGuardPSPG15152025-08-21
00850019162325Surgaflex PainGuardSFPG02032025-03-24
00850019162332Surgaflex PainGuardSFPG04062025-03-24
00850019162349Surgaflex PainGuardSFPG04102025-03-24
00850019162356Surgaflex PainGuardSFPG04202025-03-24
00850019162011Microlyte Matrix910062025-02-24
00850019162035Microlyte Matrix910072025-02-24
00850019162059Microlyte Matrix910082025-02-24
00850019162295Surgaflex910182025-02-24
00850019162301Surgaflex910172025-02-24
00850019162318Surgaflex910182025-02-24
00850019162257Microlyte Ag-Lidocaine Matrix910092025-01-21
00850019162264Microlyte Ag-Lidocaine Matrix910102025-01-21
00850019162271Microlyte Ag-Lidocaine Matrix910112025-01-21
00850019162004Microlyte Matrix910062024-07-31

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Primary DI, Brand, Company table
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