FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942228010
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1092
Catalog number
DYNDH1092
Device description
FH BREAST BIOPSY TRAY
Published
2016-09-29
Public version status
Update
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
FCGBiopsy needle
OFGCT biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942228011PackageGS120In Commercial Distribution
10889942228010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994222801140889942228011
1088994222801010889942228010

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
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
18809327353412ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355539ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355546ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355553ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355560ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355577ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355966ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355973ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355980ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355997ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356000ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356017ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356024ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356031ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356048ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356055ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356062ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356079ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356086ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
50198956320718CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956364156CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956401479CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-10
50198956323009CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-02
20884450476127CorVocet™Merit Medical Systems, Inc.FCG2026-02-28
50198956336610CARDINAL HEALTHCardinal Health 200, LLCOFG2026-02-20
00860014682926PrecisionPoint Corbin Clinical Resources, LLCFCG2026-02-04
00191072241696ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-02-02
50198956337266CARDINAL HEALTHCardinal Health 200, LLCOFG2026-01-26
00191072241559ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-01-14
50198956203936CARDINAL HEALTHCardinal Health 200, LLCOFG2025-12-17