FDA.reportPublic FDA data

Biogel® Optifit® Orthopaedic

Primary DI
05060097933983
Brand
Biogel® Optifit® Orthopaedic
Company
Mölnlycke Health Care AB
Model
31065
Device description
Biogel Optifit Orthopaedic 6.5x40US
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon's gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071465000BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTMolnlycke Health Care Us, LLC2007-09-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060097934058PackageGS140In Commercial Distribution
05060097934126PackageGS14In Commercial Distribution
05060097933983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060097934058050600979340585060097934058
05060097934126050600979341265060097934126
05060097933983050600979339835060097933983

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags#

DUNS number
631770658
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350181475Mölnlycke®Z-Flo™ Fluidized Positioner14005002026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized Positioner14005222026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized Positioner14005132026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized Positioner14005272026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized Positioner14005242026-09-22
07333350030384Tubigrip®14422026-09-21
07333350102111Tubigrip®14392026-09-21
07333350341596Mepitel®2907992026-09-21
07333350354831Tubigrip®14522026-09-21
07333350462161Mölnlycke®Z-Flo™ Fluidized Positioner14011082026-09-21
07333350472917Tubigrip®14502026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized Positioner14011052026-09-21
07333350589110Tubigrip®14342026-09-21
07333350644635Tubigrip®14372026-09-21
07333350721589Tubigrip®14352026-09-21
07333350753856Tubigrip®14482026-09-21
07333350758288Tubigrip®14382026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized Positioner14011112026-09-21
07333350929640Tubigrip®14492026-09-21
07333350094850Tubigrip®14512026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
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10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10304040195038CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.KGO2026-07-29
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09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
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09001570557889Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21