25GA Light Pipe - Alcon

Primary DI: 00632307001444
Brand: 25GA Light Pipe - Alcon
Company: Peregrine Surgical, Llc
Model: PD127.25
Device description: 25GA Light Pipe - Alcon
Published: 2016-05-06
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#

peregrine-surgical.com

Product Codes#

Code, Name table
Code	Name
MPA	Endoilluminator

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
MPA	Endoilluminator	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K980797	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K980797	000	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	Peregrine Surgical , Ltd.	1998-05-19	MPA

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
10632307001441	Package	GS1	5	In Commercial Distribution
00632307001444	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
10632307001441	10632307001441
00632307001444	00632307001444	632307001444	0632307001444

GMDN Terms#

Term, Definition table
Term	Definition
Ophthalmic fibreoptic light instrument, single-use	A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Device Size Text, specify	0
Needle Gauge	25	Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
Phone	Email
+1(215)348-0456	ryan@peregrine-surgical.com
+1(215)348-0456	jayne@peregrine-surgical.com

Regulatory Flags#

DUNS number: 622467348
Device count: 1
DM exempt: true
Lot or batch: true
Manufacturing date on label: true
Expiration date on label: true
No natural rubber latex: true
Sterilization required before use: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
00632307002144	60 Degree DMEK/DSAEK Forceps	PD427.60	2020-08-14
00632307002212	DMEK/DSAEK Forceps	PD427.00	2018-03-23
00632307002236	DMEK Forceps	PD427.00	2018-05-15
00632307002250	DMEK/DSAEK Forceps	PD427.00	2018-10-18
00632307002328	27GA Curved Illuminating Laser Probe - DORC	7627.DORC-00	2024-09-24
00632307002342	27GA Curved Illuminating Laser Probe - Iridex	7627.IRI-00	2024-09-24
00632307002359	25GA Midfield Endoillumination Probe	3269.M05-00	2024-09-24
00632307002366	27GA Midfield Endoillumination Probe	3269.M04-00	2024-09-24
00632307002373	23GA Midfield Endoillumination Probe	3269.M06-00	2024-09-24
10632307002325	27GA Curved Illuminating Laser Probe - DORC	7627.DORC-00	2024-09-24
00632307002335	27GA Curved Illuminating Laser Probe - Alcon	7627.ALC-00	2024-09-24
10632307002349	27GA Curved Illuminating Laser Probe - Iridex	7627.IRI-00	2024-09-24
10632307002356	25GA Midfield Endoillumination Probe	3269.M05-00	2024-09-24
10632307002363	27GA Midfield Endoillumination Probe	3269.M04-00	2024-09-24
10632307002370	23GA Midfield Endoillumination Probe	3269.M06-00	2024-09-24
00632307000003	20GA Straight Laser Probe - Alcon	PD720.10	2016-05-06
00632307000010	20GA Membrane Scraper	PD800.00	2016-05-06
00632307000027	20GA Non-Adjustable Membrane Scraper	PD800.20	2016-05-06
00632307000034	23GA Membrane Scraper	PD800.23	2016-05-06
00632307000041	23GA Flexible Membrane Scraper	PD800.23SF	2016-05-06

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
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00817325025010	iChopper	MEDIMAX TECH INC.	MPA	2026-04-30
00893872001684	iTrack Advance	Nova Eye, Inc.	MPA	2026-04-15
00893872001660	iLumin	Nova Eye, Inc.	MPA	2026-01-09
00840096215304	XLEND23MULTIFLEX	KATALYST SURGICAL LLC	MPA	2025-06-24
00840096215311	XLEND25MULTIFLEX	KATALYST SURGICAL LLC	MPA	2025-06-24
00810123483648	Vortex Surgical Inc.	Vortex Surgical, Inc.	MPA	2025-04-19
00810123483617	Vortex Surgical Inc.	Vortex Surgical, Inc.	MPA	2025-04-18
00810123483624	Vortex Surgical Inc.	Vortex Surgical, Inc.	MPA	2025-04-18
00810123483631	Vortex Surgical Inc.	Vortex Surgical, Inc.	MPA	2025-04-18
08717872035499	TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-04-01
08717872035543	TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-04-01
18717872035496	TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-04-01
18717872035540	TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-04-01
08717872035406	Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035420	23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035444	Shielded TotalView Endoillumination Probe, including illuminated scleral depress	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035451	TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035468	TotalView Endoillumination Probe, including illuminated scleral depressor.(25 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035475	Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035482	Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035505	TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035512	Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035529	Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035550	Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035567	Spaide TotalView Endoillumination Probe, including illuminated scleral depressor	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035581	TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
08717872035598	Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
18717872035403	Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31
18717872035427	23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	MPA	2025-03-31

25GA Light Pipe - Alcon

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#