FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489456326
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
MFDS0002A
Catalog number
MFDS0002A
Device description
STERILE FCP ROCHESTER PEAN CVD
Published
2022-08-04
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
HRQHEMOSTAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489456326PackageGS110In Commercial Distribution
10193489456325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348945632640193489456326
1019348945632510193489456325

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA 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 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
false
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
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
00810055259663Surgical DesignSurgical Design, Inc.HRQ2026-05-26
00810055259670Surgical DesignSurgical Design, Inc.HRQ2026-05-26
00810143907490SURGIPROSSurgipros, LLCHRQ2026-05-23
00810212933054SURGIPROSSurgipros, LLCHRQ2026-05-22
04059453072740Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
04059453072788Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
00810207781929Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781936Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781943Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781950Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781967Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781974Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781981Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781998Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782001Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782018Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782025Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782032Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782049Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782056Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782063Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782117Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782124Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00840183531133BR Surgical, LLCBR Surgical, LLCHRQ2025-09-29
05010058178885InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
05010058182554InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
04059453071279Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2025-09-09
00840183530631BR Surgical, LLCBR Surgical, LLCHRQ2025-08-22
00840183529567BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
00840183529574BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16