FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10080196839681
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SPEC0012
Catalog number
SPEC0012
Device description
BREAST BIOPSY TRAY
Published
2016-11-07
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196839681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019683968110080196839681

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable 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
20884450476127CorVocet™Merit Medical Systems, Inc.FCG2026-02-28
00860014682926PrecisionPoint Corbin Clinical Resources, LLCFCG2026-02-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459310Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04048223128480ChibaSonoPajunk GmbH MedizintechnologieFCG2025-07-30
08033003340806BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
08033055140300BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
04048223128268ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128275ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128336ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17