FDA.reportPublic FDA data

Medline

Primary DI
80080196028916
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS0033325
Catalog number
MDS0033325
Device description
BIOPSY PUNCH,STERILE,DISP,2.5MM,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
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20708820383351PackageGS1200In Commercial Distribution
30708820383358PackageGS11000In Commercial Distribution
00708820383357PrimaryGS10
10080196028917PrimaryGS10
80080196028916Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2070882038335120708820383351
3070882038335830708820383358
00708820383357007088203833577088203833570708820383357
1008019602891710080196028917
8008019602891680080196028916

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
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat. Keep dry. Should be shielded from direct sunlight, fluorescent lighting, x-rays, moisture and ozone.

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
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395881MEDLINEECVC2770AECVC2770A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23
00755676003021mvetADI MedicalLZA2026-10-23
00755676003052mvetADI MedicalLZA2026-10-23
00755676003083mvetADI MedicalLZA2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16