FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489192018
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2684
Catalog number
DYNDA2684
Device description
FACE/EYE PREP TRAY
Published
2020-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMPPAD, EYE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489192015PackageGS120In Commercial Distribution
10193489192018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919201520193489192015
1019348919201810193489192018

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.

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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489069334NAMIC91400300914003002021-10-28
10193489069341NAMIC91400400914004002021-07-26
10193489077667NAMIC906324490190632449012022-02-23
10193489078039NAMICH74904490202H749044902022021-07-26
10193489111132MEDLINESTGWLR1865NTSTGWLR1865NT2021-07-18
10193489111149MEDLINESTGWLR3260NTSTGWLR3260NT2021-07-18
10193489111156MEDLINESTGWLR2135NTSTGWLR2135NT2021-07-18
10193489111163MEDLINESTGWLR2535JNTSTGWLR2535JNT2021-07-18
10193489111170MEDLINESTGWLR2535NTSTGWLR2535NT2021-07-18
10193489191653MEDLINEDYNDA2467DYNDA24672020-04-15
10193489196559MEDLINEMNS12330AMNS12330A2020-04-20
10653160343806MEDLINEMNS12330AMNS12330A2020-07-06
10653160346760MEDLINEECVC7165AECVC7165A2021-05-20
10653160366577MEDLINECVI5045CVI50452023-09-28
20193489087793Medline80045075800450752021-05-12
20653160349492MEDLINEGW1850IGW1850I2021-12-16
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950396345510Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345527Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345435Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
06950396345459Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
00810124532116Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532123Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532130Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532147Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532109Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
10653160388708MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
00653160388701MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
08681756010349PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010356PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010028PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756012916PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
00690521023932Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521023949Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521025165Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
16974567748075RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
16974567748082RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748085RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
00840117334762"Eyepad - 18""x 36"" "Dynarex CorporationHMP2024-03-25
00840117334755Eyepad - 18"x 36" DYNAREX CORPORATIONHMP2024-03-25
00810077219904Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219911Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219928Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219935Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219942Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04