FDA.reportPublic FDA data

DISPOSABLE 25GA VITRECTOMY CUTTER

Primary DI
05050474534117
Brand
DISPOSABLE 25GA VITRECTOMY CUTTER
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
NGP0025
Catalog number
NGP0025
Device description
DISPOSABLE 25GA VITRECTOMY CUTTER
Published
2016-09-02
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
MLZVITRECTOMY, INSTRUMENT CUTTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLZVitrectomy, Instrument CutterOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15050474534114PackageGS16In Commercial Distribution
05050474534117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505047453411415050474534114
05050474534117050504745341175050474534117

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system handpieceA holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
103021940
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380650000187UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531745UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531776UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380650000184UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380657531742UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380657531773UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531752UNITYAlcon Laboratories, Inc.MLZ2024-11-19
00380657531769UNITYAlcon Laboratories, Inc.MLZ2024-11-19
10380657531759UNITYAlcon Laboratories, Inc.MLZ2024-11-19
10380657531766UNITYAlcon Laboratories, Inc.MLZ2024-11-19
00380650002501UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531677UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531684UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531790UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380650002508UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531674UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531681UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531797UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00850005541042MICOR VitrectorCarl Zeiss Meditec, Cataract Technology, Inc.MLZ2023-07-28
00191072142832ACSAMERICAN CONTRACT SYSTEMS, INC.MLZ2021-08-10
00191072121974ACSAMERICAN CONTRACT SYSTEMS, INC.MLZ2021-01-27
00380650000958CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380650000965CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380657531066CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380657531097CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380658300777CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380650000955CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380650000962CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380657531063CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11