FDA.reportPublic FDA data

Premier Kevorkian Biopsy Forcep

Primary DI
00348783001785
Brand
Premier Kevorkian Biopsy Forcep
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9086440
Device description
FORCEP BIOPSY KEVORKIAN- GERMAN 10 IN
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00348783001785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783001785003487830017853487830017850348783001785

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
014789663
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783004069Premier Elevator100336010033622026-03-17
00348783004076Premier Elevator100336110033632026-03-17
00348783004182Premier Elevator100338410033862026-03-17
00348783004229Premier Elevator100339410033962026-03-17
00348783005929Premier Explorers10035092026-03-17
00348783005974Premier Explorers10035152026-03-17
00348783005998Premier Explorers10035232026-03-17
00348783006018Premier Explorers10035262026-03-17
00348783006056Premier Explorers10035392026-03-17
00348783006063Premier Explorers10035492026-03-17
00348783006186Premier Explorers10035602026-03-17
00348783006223Premier Explorers10035652026-03-17
00348783006438Premier Probes10036702026-03-17
00348783006629Premier Probes10036902026-03-17
00348783006766Premier Probes90061022026-03-17
00348783006780Premier Probes90061052026-03-17
00348783006803Premier Probes90061072026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
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
16973672291056JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
00190776406974MillenniumAvalign Technologies, Inc.HFB2025-07-25
05010058182592InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058180475InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
00190776401771MillenniumAvalign Technologies, Inc.HFB2025-06-13
00198506083013ELMED INCORPORATEDELMED INCORPORATEDHFB2025-05-22
05010058182585InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
00840183530112BR Surgical, LLCBR Surgical, LLCHFB2025-05-14
04049047044215GimmiGimmi GmbHHFB2025-05-14
04049047044246GimmiGimmi GmbHHFB2025-05-14
04049047044291GimmiGimmi GmbHHFB2025-05-14
04049047655664GimmiGimmi GmbHHFB2025-05-14
04049047043973GimmiGimmi GmbHHFB2025-05-13
04049047043997GimmiGimmi GmbHHFB2025-05-13
04049047044048GimmiGimmi GmbHHFB2025-05-13
04049047044062GimmiGimmi GmbHHFB2025-05-13
04049047044086GimmiGimmi GmbHHFB2025-05-13
04049047044093GimmiGimmi GmbHHFB2025-05-13
04049047647706GimmiGimmi GmbHHFB2025-05-13
04049047655503GimmiGimmi GmbHHFB2025-05-13