FDA.report

MEDLINE

Primary DI
00653160388701
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
M101561
Catalog number
M101561
Device description
EYE DONOR PREP KIT
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HMPPAD, EYE

Product Code Classifications

CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160388701PackageGS120In Commercial Distribution
10653160388708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160388701006531603887016531603887010653160388701
1065316038870810653160388708

GMDN Terms

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

Contacts

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

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10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
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10197344039845MEDLINEHNY19150HNY191502024-10-11
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10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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