FDA.reportPublic FDA data

TPC

Primary DI
20888937022708
Brand
TPC
Company
Coopersurgical, Inc.
Model
LBCR-OD20
Device description
Biopsy Pipette
Published
2020-04-03
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

Product Codes#

Code, Name table
CodeName
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUCMicrotools, Assisted Reproduction (Pipettes), ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937022708PackageGS110In Commercial Distribution
00888937022704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702270820888937022708
00888937022704008889370227048889370227040888937022704

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972598790455Holding pipettesGuangzhou PINZHI Medical Device Co., Ltd.PUC2026-03-06
06972598791865Biopsy pipettesGuangzhou PINZHI Medical Device Co., Ltd.PUC2025-12-15
10827002609898COOKCook Vandergrift Inc.PUC2025-07-24
10827002610139COOKCook Vandergrift Inc.PUC2025-07-24
10827002610146COOKCook Vandergrift Inc.PUC2025-07-24
10827002610153COOKCook Vandergrift Inc.PUC2025-07-24
00858604006061Intelligent ICSI MicropipetteHAMILTON THORNE, INC.PUC2024-12-11
00850068289004SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289011SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289028SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289035SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289042SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289059SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289066SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289073SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289080SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289097SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289103SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289110SFG Denuding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289127SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289134SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289141SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289158SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289165SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289172SFG ICSI pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289189SFG Holding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289196SFG Holding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289202SFG Holding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289219SFG Holding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12
00850068289226SFG Holding pipettesSPECTRUM FERTILITY GROUP INC.PUC2024-11-12