FDA.reportPublic FDA data

Zip PreLoc 2 Wound Closure Device

Primary DI
10853114007277
Brand
Zip PreLoc 2 Wound Closure Device
Company
ZIPLINE MEDICAL, INC.
Model
PS3002
Catalog number
PS3002
Device description
Zip PreLoc 2 Wound Closure Device
Published
2020-05-21
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
MKYSystem, Skin Closure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853114007277PackageGS15In Commercial Distribution
00853114007270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085311400727710853114007277
00853114007270008531140072708531140072700853114007270

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
Width2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT AND HEAT
Special Storage Condition, Specify00Keep away from sunlight and heat. Keep Dry.
Special Storage Condition, Specify00Keep away from sunlight and heat. Keep Dry.
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-253-3210INS.Stryker.CS@stryker.com
+1(800)253-3210INS.Stryker.CS@stryker.com
+1(800)253-3210inst.stryker.cs@stryker.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
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
10853114007086Zip 8i Surgical Skin Closure Device9000080019000080012018-08-02
10853114007093Zip 16 Surgical Skin Closure Device9000160019000160012018-08-02
10853114007109Zip 24 Surgical Skin Closure Device9000240019000240012018-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611497ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28