FDA.report

Denudation Pipettes

Primary DI
06972598792053
Brand
Denudation Pipettes
Company
Guangzhou PINZHI Medical Device Co., Ltd.
Model
S-P-PD210/10
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQHMicrotools, Assisted Reproduction (Pipettes)

Product Code Classifications

CodeDeviceSpecialtyClass
MQHMicrotools, Assisted Reproduction (Pipettes)Obstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K250838000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06972598792053PrimaryGS10
16972598792050Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06972598792053069725987920536972598792053
1697259879205016972598792050

GMDN Terms

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.

Regulatory Flags

DUNS number
418527269
Device count
10
DM exempt
true
Premarket exempt
false
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06972598792039Denudation PipettesS-P-PD130/102026-05-22
06972598792046Denudation PipettesS-P-PD160/102026-05-22
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
06972598791902Denudation PipettesS-P-PD290/102025-12-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972598792039Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2026-05-22
06972598792046Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2026-05-22
06972598791872Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2025-12-15
06972598791889Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2025-12-15
06972598791896Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2025-12-15
06972598791902Denudation PipettesGuangzhou PINZHI Medical Device Co., Ltd.MQH2025-12-15
05060488046858EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046865EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046872EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046889EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046896EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046902EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046919EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046926EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046933EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046940EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046957EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046964EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046971EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046988EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046995EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047008EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047015EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047022EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047039EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047046EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047053EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047060EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047077EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047084EZ-TipCoopersurgical, Inc.MQH2025-04-11