FDA.reportPublic FDA data

Biogel® PI

Primary DI
05060097938001
Brand
Biogel® PI
Company
Mölnlycke Health Care AB
Model
40880
Device description
Biogel PI 8.0 x50 US
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060097937929PackageGS150In Commercial Distribution
05060097938001PackageGS14In Commercial Distribution
05060097937844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060097937929050600979379295060097937929
05060097938001050600979380015060097938001
05060097937844050600979378445060097937844

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene 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. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
631770658
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350377205Mepore®3319002026-05-23
07333350625993Mepore®3320002026-05-23
07323190091171Biogel® PI Micro Indicator® System483552026-03-02
07323190091218Biogel® PI Micro Indicator® System483602026-03-02
07323190091263Biogel® PI Micro Indicator® System483652026-03-02
07323190091300Biogel® PI Micro Indicator® System483702026-03-02
07323190091348Biogel® PI Micro Indicator® System483752026-03-02
07323190091379Biogel® PI Micro Indicator® System483802026-03-02
07323190091454Biogel® PI Micro Indicator® System483852026-03-02
07333350045845Mepilex® Transfer2948992026-02-26
07333350416249Mepilex® Transfer2945992026-02-26
07333350703745Tortoise™ Turning & positioning system14008102026-02-11
07333350636012Tortoise™ Turning & positioning system14008112026-02-11
07333350692483Mepilex®2941992026-01-25
07333350865382Mepilex® Lite2841902026-01-25
07333350291266Mepilex® Lite2843902026-01-25
07333350384036Mepilex®2942992026-01-25
07333350018757Mepilex® Lite2840902026-01-25
07333350805357Mepilex®2944992026-01-25
07333350140922Mepilex®2940902026-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07323190091171Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091218Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091263Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091300Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091348Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091379Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091454Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
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00841277110807Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
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00841277110821Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110838Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110845Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110852Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110869Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
30888277347902MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
30888277347926MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
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40080196307525MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40080196307549MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20080196417305MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40888277347916MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277347933MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417124MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417131MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417148MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417158MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417162MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417172MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417186MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01