FDA.reportPublic FDA data

Incise Film

Primary DI
10813465012191
Brand
Incise Film
Company
HURRICANE MEDICAL INC
Model
9701
Catalog number
9701
Device description
Cover lashes, lids, and brow for ophthalmic surgery, or office procedures. Adhesive area 12.7 x 18.4 cm.
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813465012194PrimaryGS10
10813465012191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465012194008134650121948134650121940813465012194
1081346501219110813465012191

GMDN Terms#

Term, Definition table
TermDefinition
Hypoallergenic skin adhesive tapeA flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22.8Centimeter
Width12.7Centimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
093377724
Device count
20
DM exempt
true
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813465012071Surgical Glide920192012020-05-05
00813465012101IOL Glide - Sheets920492042020-05-05
00813465011135IOL Manipulator - Lester680168012020-05-08
00813465011142IOL Manipulator - Sinskey680268022020-05-08
00813465011166IOL Manipulator - Sinskey680468042020-05-08
00813465011173Nucleus Chopper - P. Koch681068102020-05-08
00813465011180Nucleus Chopper - Beckingsale681168112020-05-08
10813465011132IOL Manipulator - Lester680168012020-05-08
10813465011149IOL Manipulator - Sinskey680268022020-05-08
10813465011163IOL Manipulator - Sinskey680468042020-05-08
10813465011170Nucleus Chopper - P. Koch681068102020-05-08
10813465011187Nucleus Chopper - Beckingsale681168112020-05-08
00813465011197Silicone Tubing700270022020-05-07
00813465011319Marker Pad - Gentian Violet730373032020-05-07
00813465011326Marker Pad - Methylene Blue730473042020-05-07
00813465011432Dual Tip Marker Pen - Gentian Violet731973192020-05-07
00813465011449Dual Tip Marker Pen - Methylene Blue732073202020-05-07
00813465012125.20 Micron Filter930193012020-05-07
00813465012149Male to Male Luer Connector930393032020-05-07
10813465011194Silicone Tubing700270022020-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25