FDA.reportPublic FDA data

Alcon Eye-Pak

Primary DI
10380651028200
Brand
Alcon Eye-Pak
Company
Alcon Laboratories, Inc.
Model
8065102820
Device description
Eye Pak* 1028 Plastic Ophthalmic Drape-Strabismus APERTURE
Published
2016-09-24
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
HMTDrape, patient, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830822000EYE DRAPECooperVision, Inc.1983-04-06HMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380651028200PackageGS110In Commercial Distribution
00380651028203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065102820010380651028200
00380651028203003806510282033806510282030380651028203

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344179685MEDLINEMEDLINE INDUSTRIES, INC.HMT2026-02-12
10192253066630CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066647CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066661CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066678CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066685CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066638CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066645CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066669CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066676CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066683CONVERTORSCardinal Health 200, LLCHMT2025-06-18
00380650003904UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003911UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650004185UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003901UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003918UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650004182UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003881ALCONAlcon Laboratories, Inc.HMT2024-07-02
10380650003888ALCONAlcon Laboratories, Inc.HMT2024-07-02
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10326053120593Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
10326053120630Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
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