FDA.report

comknife®

Primary DI
16971503601210
Brand
comknife®
Company
Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Model
JPD-QG-Z-333
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

Related Records

Product Codes

CodeName
GDZHandle, Scalpel

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16971503601210PackageGS16In Commercial Distribution
26971503601125PackageGS1300In Commercial Distribution
06971503602296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697150360121016971503601210
2697150360112526971503601125
06971503602296069715036022966971503602296

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
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
16971503600121comknife®JPD-PQ-L-1132025-09-02
26937372516700comknife®JPD-BL-B-1182025-08-29
16937372516604comknife®JPD-QG-L-2822025-08-29
16937372516611comknife®JPD-QG-L-2832025-08-29
16937372516628comknife®JPD-KQ-L-2782025-08-29
16937372516635comknife®JPD-KQ-L-2792025-08-29
16937372516642comknife®JPD-KQ-L-2802025-08-29
16937372516659comknife®JPD-KQ-L-2812025-08-29
16971503601340comknife®JPD-QG-W-4022025-08-29
16971503601357comknife®JPD-QG-W-4102025-08-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776418038MillenniumAvalign Technologies, Inc.GDZ2026-03-23
16937372521523comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521530comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521547comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521554comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521561comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521578comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
B382SD4811280Surgical DirectSurgical Direct, Inc.GDZ2026-02-16
00190776416157MillenniumAvalign Technologies, Inc.GDZ2026-02-06
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
09348811000019INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000095INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000132INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000149INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000170INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000187INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000194INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000200INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000217INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000224INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014146INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014856INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014863INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811151452INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-01-22
00841013120480Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-06
00841013124327American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02
00841013124334American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02