FDA.reportPublic FDA data

Biogel Sensor®

Primary DI
05060097932474
Brand
Biogel Sensor®
Company
Mölnlycke Health Care AB
Model
82570
Device description
Biogel Super Sensitive 7.0x50 US EUR
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071700000BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTMolnlycke Health Care Us, LLC2007-09-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060097932474PackageGS150In Commercial Distribution
05060097932559PackageGS14In Commercial Distribution
05060097932399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060097932474050600979324745060097932474
05060097932559050600979325595060097932559
05060097932399050600979323995060097932399

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350012946Mepiform®2932112026-10-29
07333350064938Biogel® PI Micro Indicator® Underglove66489702026-10-29
07333350119621Biogel® PI Micro Indicator® System66483702026-10-29
07333350176181Biogel® PI Micro Indicator® Underglove66489602026-10-29
07333350400149Mepiform®2931112026-10-29
07333350407926Biogel® PI Micro Indicator® System66483652026-10-29
07333350581305Biogel® PI Micro Indicator® System66483602026-10-29
07333350600297Mepiform®2934012026-10-29
07333350696177Biogel® PI Micro66485652026-10-29
07333350861582Biogel® PI Micro Indicator® Underglove66489652026-10-29
07333350974121Biogel® PI Micro66485602026-10-29
07333350999124Biogel® PI Micro Indicator® Underglove66489752026-10-29
07333350811372Biogel® PI Micro66485702026-10-20
07333350937461Mepiform®2931992026-10-20
07333350635428Mepiform®2934992026-10-16
07333350898588Mepiform®2932992026-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350064938Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350119621Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350176181Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350407926Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350581305Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350696177Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350861582Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350974121Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350999124Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
10809160542125HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
00755676002369mvetADI MedicalKGO2026-10-26
00755676002376mvetADI MedicalKGO2026-10-26
00755676002413mvetADI MedicalKGO2026-10-26
00755676002437mvetADI MedicalKGO2026-10-26
00755676002451mvetADI MedicalKGO2026-10-26
00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
10809160538968HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-24
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