Denudation Pipettes

Primary DI
06972598791902
Brand
Denudation Pipettes
Company
Guangzhou PINZHI Medical Device Co., Ltd.
Model
S-P-PD290/10
Published
2025-12-15
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
MQHMicrotools, Assisted Reproduction (Pipettes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQHMicrotools, Assisted Reproduction (Pipettes)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250838000Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.2025-07-03MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972598791902PrimaryGS10
16972598791909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972598791902069725987919026972598791902
1697259879190916972598791909

GMDN Terms#

Term, Definition table
TermDefinition
User-induced micropipetteA long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418527269
Device count
10
DM 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
06972598792039Denudation PipettesS-P-PD130/102026-05-22
06972598792046Denudation PipettesS-P-PD160/102026-05-22
06972598792053Denudation PipettesS-P-PD210/102026-05-22
16972598790452Holding pipettesI-P-H30.100M2026-03-06
06972598790455Holding pipettesI-P-H30.100M2026-03-06
06972598791865Biopsy pipettesS-P-B35.302025-12-15
06972598791872Denudation PipettesS-P-PD140/102025-12-15
06972598791889Denudation PipettesS-P-PD150/102025-12-15
06972598791896Denudation PipettesS-P-PD170/102025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10805360016442Biopsy PipetteVITROLIFE INC.MQH2020-07-13
10805360019283ICSI PipetteVITROLIFE INC.MQH2020-04-28
10805360019290ICSI PipetteVITROLIFE INC.MQH2020-04-28
10805360019313ICSI PipetteVITROLIFE INC.MQH2020-04-28
10805360019320ICSI PipetteVITROLIFE INC.MQH2020-04-28
10805360019337ICSI PipetteVITROLIFE INC.MQH2020-04-28
15019315081248WallaceICU MEDICAL, INC.MQH2016-12-15
15019315077203WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077210WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077227WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077234WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077241WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077258WallaceICU MEDICAL, INC.MQH2016-10-19
15019315077265WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081200WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081217WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081224WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081231WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081255WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081262WallaceICU MEDICAL, INC.MQH2016-10-19
15019315081279WallaceICU MEDICAL, INC.MQH2016-10-19
15019315083044WallaceICU MEDICAL, INC.MQH2016-10-19
15019315083051WallaceICU MEDICAL, INC.MQH2016-10-19
15019315080890WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080906WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080913WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080920WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080937WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080944WallaceICU MEDICAL, INC.MQH2016-10-11
15019315080951WallaceICU MEDICAL, INC.MQH2016-10-11