FDA.reportPublic FDA data

Eyepad - 18"x 36"

Primary DI
00840117334755
Brand
Eyepad - 18"x 36"
Company
DYNAREX CORPORATION
Model
3361UB-2
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00840117334748PackageGS1100In Commercial Distribution
00840117334755PackageGS12In Commercial Distribution
00840117334762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117334748008401173347488401173347480840117334748
00840117334755008401173347558401173347550840117334755
00840117334762008401173347628401173347620840117334762

GMDN Terms#

Term, Definition table
TermDefinition
Eye padA cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

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
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
00810077219959Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04