FDA.reportPublic FDA data

KEMIS

Primary DI
03700569640675
Brand
KEMIS
Company
NEWCLIP TECHNICS
Model
ANC1103
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569660017PackageGS15In Commercial Distribution
03700569640675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569660017037005696600173700569660017
03700569640675037005696406753700569640675

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.

Regulatory Flags#

DUNS number
263281904
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569658212Xpert PFPFT5.6D-STFT5.6D-ST2026-06-03
00370056966385Xpert PFPQTDE1D-STQTDE1D-ST2026-06-02
03700569658151Xpert PFPQTDP-E1D-STQTDP-E1D-ST2026-06-02
03700569658175Xpert PFPQTDP-E2D-STQTDP-E2D-ST2026-06-02
03700569658199Xpert PFPQTGPH2D-STQTGPH2D-ST2026-06-02
03700569662202Xpert PFPQTSM1D-STQTSM1D-ST2026-06-02
03700569663247Xpert PFPQTDE2D-STQTDE2D-ST2026-06-02
03700569663841Xpert PFPQTGE2D-STQTGE2D-ST2026-06-02
03700569663865Xpert PFPQTDE3D-STQTDE3D-ST2026-06-02
03700569663872Xpert PFPQTDP1D-STQTDP1D-ST2026-06-02
03700569663889Xpert PFPQTDP2D-STQTDP2D-ST2026-06-02
03700569663896Xpert PFPQTDP3D-STQTDP3D-ST2026-06-02
03700569663902Xpert PFPQTGP3D-STQTGP3D-ST2026-06-02
03700569663919Xpert PFPQTGP2D-STQTGP2D-ST2026-06-02
03700569663926Xpert PFPQTGP1D-STQTGP1D-ST2026-06-02
03700569663933Xpert PFPQTGE1D-STQTGE1D-ST2026-06-02
03700569663940Xpert PFPQTGE3D-STQTGE3D-ST2026-06-02
03700569663964Xpert PFPQTSM3D-STQTSM3D-ST2026-06-02
03700569671327Xpert PFPQTGP-E1D-STQTGP-E1D-ST2026-06-02
03700569676438Xpert PFPQTDPH1D-STQTDPH1D-ST2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419783MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776418410MillenniumAvalign Technologies, Inc.GDZ2026-03-25
09348811000040INKAThe Trustee for KAISER FAMILY TRUSTGDZ2025-11-19
B382SD9045551000Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551010Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551020Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551030Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
16945630137621index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
16945630137638index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
38886354702639Anzen Safety ScalpelMEDIPURPOSE PTE. LTD.GDZ2025-02-12
B382SD904320210Surgical DirectSurgical Direct, Inc.GDZ2024-07-11
M944AL019130Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
M944AL019230Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
14026704922991PILLINGTELEFLEX INCORPORATEDGDZ2023-11-07
10620974003318SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003325SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003332SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003349SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003356SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
G25001001030Scalpel Handle No.3N S SURGICAL COMPANYGDZ2023-01-31
G25001002040Scalpel Handle No.4N S SURGICAL COMPANYGDZ2023-01-31