FDA.reportPublic FDA data

Medline

Primary DI
20888277386690
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
806575021R
Catalog number
806575021R
Device description
8065750263 @TURBOSONICS TAPERED ABS MICR
Published
2023-10-09
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
NKXNeedle, phacoemulsification, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKXNeedle, Phacoemulsification, ReprocessedOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277386690PackageGS16In Commercial Distribution
10888277386693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827738669020888277386690
1088827738669310888277386693

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification system handpiece tip, reprocessedA device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277353985MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277354395MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277354562MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277368958MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277368996MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277373549MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277373556MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277375475MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277375482MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277375499MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277375505MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277380462MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277381780MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277384774MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277385580MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277388314MEDLINEMEDLINE INDUSTRIES, INC.NKX2025-01-29
10888277386464MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NKX2025-01-14
20888277386461MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NKX2025-01-14
10888277386693MedlineMEDLINE INDUSTRIES, INC.NKX2023-10-09
04049539100177PHACO TIP WRENCHCarl Zeiss Meditec AGNKX2022-04-25
10888277375512Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277377271Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277377622Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277380479Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277381803Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277383449Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277385917Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14
10888277387201Medline ReNewalMEDLINE INDUSTRIES, INC.NKX2016-10-14