FDA.reportPublic FDA data

WickiMed

Primary DI
26970739450057
Brand
WickiMed
Company
WickiMed (Hui Zhou) Medical Equipment Manufacturing Co., Ltd.
Model
138506
Device description
Tungsten Micro Needle 4cm Straight
Published
2022-01-14
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

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26970739450057PackageGS140In Commercial Distribution
06970739450053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697073945005726970739450057
06970739450053069707394500536970739450053

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
528182887
Device count
1
DM exempt
false
Premarket exempt
false
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
true
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
06970739450015WickiMed1385042022-01-14
06970739450022WickiMed138504-102022-01-14
06970739450039WickiMed1385052022-01-14
06970739450046WickiMed138505-102022-01-14
06970739450053WickiMed1385062022-01-14
06970739450060WickiMed138506-102022-01-14
26970739450019WickiMed1385042022-01-14
26970739450026WickiMed138504-102022-01-14
26970739450033WickiMed1385052022-01-14
26970739450040WickiMed138505-102022-01-14
26970739450064WickiMed138506-102022-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10