FDA.reportPublic FDA data

Zip 8i Surgical Skin Closure Device

Primary DI
10853114007086
Brand
Zip 8i Surgical Skin Closure Device
Company
ZIPLINE MEDICAL, INC.
Model
900008001
Catalog number
900008001
Device description
Zip 8i Surgical Skin Closure Device, BSN
Published
2018-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10853114007086PackageGS110In Commercial Distribution
00853114007089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085311400708610853114007086
00853114007089008531140070898531140070890853114007089

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and heat. Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-326-8999customerservice@ziplinemedical.com

Regulatory Flags#

DUNS number
962534124
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853114007003Zip 4 Surgical Skin Closure Device66761300176132017-03-16
00853114007010Zip 8i Surgical Skin Closure Device66761400176142017-03-16
00853114007027Zip 16 Surgical Skin Closure Device66761500176152017-03-16
00853114007034Zip 24 Surgical Skin Closure Device66761600176162017-03-16
00853114007072Zip 4 Surgical Skin Closure Device9000040019000040012018-08-02
00853114007089Zip 8i Surgical Skin Closure Device9000080019000080012018-08-02
00853114007096Zip 16 Surgical Skin Closure Device9000160019000160012018-08-02
00853114007102Zip 24 Surgical Skin Closure Device9000240019000240012018-08-02
00853114007119Zip 16 Surgical Skin Closure DevicePS1160PS11602018-08-02
00853114007126Zip 24 Surgical Skin Closure DevicePS1240PS12402018-08-02
00865379000026Zip 4 Surgical Skin Closure DevicePS2040PS20402018-08-02
10853114007277Zip PreLoc 2 Wound Closure DevicePS3002PS30022020-05-21
10853114007192Zip 4 Surgical Skin Closure DevicePS2040PS20402019-05-16
10853114007000Zip 4 Surgical Skin Closure Device66761300176132017-03-16
10853114007017Zip 8i Surgical Skin Closure Device66761400176142017-03-16
10853114007024Zip 16 Surgical Skin Closure Device66761500176152017-03-16
10853114007031Zip 24 Surgical Skin Closure Device66761600176162017-03-16
10853114007079Zip 4 Surgical Skin Closure Device9000040019000040012018-08-02
10853114007093Zip 16 Surgical Skin Closure Device9000160019000160012018-08-02
10853114007109Zip 24 Surgical Skin Closure Device9000240019000240012018-08-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11