FDA.reportPublic FDA data

Medline

Primary DI
80080196024857
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS0033310
Catalog number
MDS0033310
Device description
DBD-BIOPSY PUNCH,STERILE,DISP,1MM,50/BX
Published
2024-09-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMEPunch, Biopsy, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196024858PrimaryGS10
80080196024857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019602485810080196024858
8008019602485780080196024857

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
50
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40649111231422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233150Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233501Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111234102Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336128712Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336113534Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2024-12-11
80080196029135MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196029210MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
80080196030315MedlineMEDLINE INDUSTRIES, INC.EME2024-10-01
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80080196025748MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
80080196028992MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
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80080196024949MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
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10193489141139MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
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10193489141207MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141214MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
10193489141238MedlineMEDLINE INDUSTRIES, INC.EME2024-03-27
08800075612755OSUNG MNDOSUNG MND Co., Ltd.EME2024-03-04
08800075612762OSUNG MNDOSUNG MND Co., Ltd.EME2024-03-04
08800075612779OSUNG MNDOSUNG MND Co., Ltd.EME2024-03-04