FDA.reportPublic FDA data

comknife®

Primary DI
16937372515010
Brand
comknife®
Company
Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Model
JPD-CC-P-237
Device description
Are intended for delicate dissection and stripping of blood vessels and soft tissues in surgery or microsurgery
Published
2025-08-27
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
GDZHandle, Scalpel

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16937372515010PackageGS16In Commercial Distribution
26937372515017PackageGS1300In Commercial Distribution
06937372515013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693737251501016937372515010
2693737251501726937372515017
06937372515013069373725150136937372515013

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

Regulatory Flags#

DUNS number
552747785
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
true
No natural rubber latex
false
Sterilization required before use
false

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
06971503609035comknife®JPD-PQ-L-1132025-09-02
16937372521417comknife®JPD-CQ-L-1442025-09-02
16937372521424comknife®JPD-DT-L-7302025-09-02
16937372521431comknife®JPD-DT-L-7312025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07708626670395SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SGDZ2023-01-18
B356BH103010American MedicalsAmerican MedicalsGDZ2023-01-02
00386120012230MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012247MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012254MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012261MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09