FDA.reportPublic FDA data

60 Degree DMEK/DSAEK Forceps

Primary DI
00632307002144
Brand
60 Degree DMEK/DSAEK Forceps
Company
Peregrine Surgical, Llc
Model
PD427.60
Device description
60 Degree DMEK/DSAEK Forceps
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00632307002144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00632307002144006323070021446323070021440632307002144

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, reusableA hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
215-348-0456ryan@peregrine-surgical.com

Regulatory Flags#

DUNS number
622467348
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00632307002212DMEK/DSAEK ForcepsPD427.002018-03-23
00632307002236DMEK ForcepsPD427.002018-05-15
00632307002250DMEK/DSAEK ForcepsPD427.002018-10-18
0063230700232827GA Curved Illuminating Laser Probe - DORC7627.DORC-002024-09-24
0063230700234227GA Curved Illuminating Laser Probe - Iridex7627.IRI-002024-09-24
0063230700235925GA Midfield Endoillumination Probe3269.M05-002024-09-24
0063230700236627GA Midfield Endoillumination Probe3269.M04-002024-09-24
0063230700237323GA Midfield Endoillumination Probe3269.M06-002024-09-24
1063230700232527GA Curved Illuminating Laser Probe - DORC7627.DORC-002024-09-24
0063230700233527GA Curved Illuminating Laser Probe - Alcon7627.ALC-002024-09-24
1063230700234927GA Curved Illuminating Laser Probe - Iridex7627.IRI-002024-09-24
1063230700235625GA Midfield Endoillumination Probe3269.M05-002024-09-24
1063230700236327GA Midfield Endoillumination Probe3269.M04-002024-09-24
1063230700237023GA Midfield Endoillumination Probe3269.M06-002024-09-24
0063230700000320GA Straight Laser Probe - AlconPD720.102016-05-06
0063230700001020GA Membrane ScraperPD800.002016-05-06
0063230700002720GA Non-Adjustable Membrane ScraperPD800.202016-05-06
0063230700003423GA Membrane ScraperPD800.232016-05-06
0063230700004123GA Flexible Membrane ScraperPD800.23SF2016-05-06
0063230700005825GA Membrane ScraperPD800.252016-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16
00190776434885MillenniumAvalign Technologies, Inc.HNR2026-10-14
00190776434984MillenniumAvalign Technologies, Inc.HNR2026-10-14
00192896123939Bishop Harmon Tissue ForcepsSONTEC INSTRUMENTS, INC.HNR2026-10-14
G346EA41VSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-14
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
G223M111991S0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-10-01
00190776432942MillenniumAvalign Technologies, Inc.HNR2026-09-30
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25