FDA.reportPublic FDA data

"BABY TISCHLER BIOPSY PUNCH 10"""

Primary DI
G422BP0190
Brand
"BABY TISCHLER BIOPSY PUNCH 10"""
Company
BIOPSY FINE CUT INSTRUMENTS
Model
BP019
Catalog number
BP019
Device description
"Size 10""Made by Stainless Steel"
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G422BP0191PackageHIBCC2In Commercial Distribution
G422BP0190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645680898
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G422BP0110TISCHLER OVAL 21CMBP011BP0112024-10-03
G422SP0030GRAVES VAG SPEC LG 4.5SP003SP0032024-10-03
G422BP0120TISCHLER KEVORKIAN BIOPSY PUNCHBP012BP0122023-11-28
G422BP0180"TISCHLER MORGAN BIOPSY PUNCH 10"""BP018BP0182023-10-13
G422BP1090"ROTO TISCHLER BIOPSY PUNCH 10"""BP109BP1092023-10-13
G422BP0181TISCHLER MORGAN BIOPSY PUNCH 10"BP018BP0182023-10-13
G422BP0191BABY TISCHLER BIOPSY PUNCH 10"BP019BP0192023-10-13
G422BP1091ROTO TISCHLER BIOPSY PUNCH 10"BP109BP1092023-10-13
G422DL0030MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MMDL003DL0032023-10-13
G422DL1010DILATOR CERVICAL SET OF 6DL101DL1012023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRDL300DL3002023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)DL301DL3012023-10-13
G422FC0060INSTRUMENT F. REMOVAL OF I.U.D FC006FC0062023-10-13
G422LZ1080"Lletz TENACULUM FORCEPS 9.5"""LZ108LZ1082023-10-13
G422SP1040PEDERSON SPECULUM MEDIUMSP104SP1042023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950190431006NAZhuji Pengtian Medical Instrument Co.,Ltd.HFB2026-03-31
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
06973672291066JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
16973672291063JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
00194613029302MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613033590MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613060480MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613106423MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613108076MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117641MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117726MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
06973672291059JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
16973672291056JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
00190776406974MillenniumAvalign Technologies, Inc.HFB2025-07-25
05010058082595InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058182592InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058080478InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
05010058180475InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
00190776401771MillenniumAvalign Technologies, Inc.HFB2025-06-13
00198506083013ELMED INCORPORATEDELMED INCORPORATEDHFB2025-05-22
05010058082588InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
05010058182585InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
00840183530112BR Surgical, LLCBR Surgical, LLCHFB2025-05-14
04049047044215GimmiGimmi GmbHHFB2025-05-14
04049047044246GimmiGimmi GmbHHFB2025-05-14
04049047044291GimmiGimmi GmbHHFB2025-05-14