FDA.reportPublic FDA data

comknife®

Primary DI
06971503609035
Brand
comknife®
Company
Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Model
JPD-PQ-L-113
Device description
Are intended for delicate dissection and stripping of blood vessels and soft tissues in surgery or microsurgery
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
16971503600121PackageGS120In Commercial Distribution
26937372516670PackageGS1100In Commercial Distribution
06971503609035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697150360012116971503600121
2693737251667026937372516670
06971503609035069715036090356971503609035

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
552747785
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937372521526comknife®JPD-DT-L-7322026-03-19
06937372521533comknife®JPD-DT-L-7332026-03-19
06937372521540comknife®JPD-DT-L-7342026-03-19
06937372521557comknife®JPD-DT-L-7352026-03-19
06937372521564comknife®JPD-DT-L-7362026-03-19
06937372521571comknife®JPD-DT-L-7372026-03-19
16937372521523comknife®JPD-DT-L-7322026-03-19
16937372521530comknife®JPD-DT-L-7332026-03-19
16937372521547comknife®JPD-DT-L-7342026-03-19
16937372521554comknife®JPD-DT-L-7352026-03-19
16937372521561comknife®JPD-DT-L-7362026-03-19
16937372521578comknife®JPD-DT-L-7372026-03-19
06937372521410comknife®JPD-CQ-L-1442025-09-02
06937372521427comknife®JPD-DT-L-7302025-09-02
06937372521434comknife®JPD-DT-L-7312025-09-02
06937372521441comknife®JPD-DT-Z-6122025-09-02
16937372521417comknife®JPD-CQ-L-1442025-09-02
16937372521424comknife®JPD-DT-L-7302025-09-02
16937372521431comknife®JPD-DT-L-7312025-09-02
16937372521448comknife®JPD-DT-Z-6122025-09-02

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