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
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D5052200TENNAT TYING FORCEPS STR DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052300TENNAT TYING FORCEPS CVD DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052340MAUMENEE TYING FORCEPS STRDAUD JEE MFG. COHNR2023-01-05
G006D5052350MAUMENEE TYING FORCEPS ANGDAUD JEE MFG. COHNR2023-01-05
G006D5054000HARMS TYING FORCEPS STR STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5054100HARMS TYING FORCEPS CVD STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5051120ANIS TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-21
G006D5051130ANIS TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-21
G006D5051900FREEMAN-JAFFE LENS HOLDING FORCEPSDAUD JEE MFG. COHNR2022-12-21
G006D5052000JAFFE TYING FORCEPS STRAIGHT DAUD JEE MFG. COHNR2022-12-21
G006D5052100JAFFE TYING FORCEPS CURVED DAUD JEE MFG. COHNR2022-12-21
G006D5051000SINSKEY TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-20
G006D5051100SINSKEY TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-20
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50313000Capsulorhexis Forceps G PATTERNDAUD JEE MFG. COHNR2022-12-19
G006D504050810 CAPS FORCEPS RND HDL STR DAUD JEE MFG. COHNR2022-12-19
G006D505000910CAPSULORRHEXIS FORCEPS ROUND HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D505000990CAPSULORRHEXIS FORCEPS FOR MICRO COXIAL 2MMDAUD JEE MFG. COHNR2022-12-19
G006D506000000CAPSULORRHEXIS FORCEPS FOR MICS/MCCSDAUD JEE MFG. COHNR2022-12-19
G006D506000020CAPSULORRHEXIS FORCEPS 12MMDAUD JEE MFG. COHNR2022-12-19
G006D506000030CAPSULORRHEXIS FORCEPS 11MMDAUD JEE MFG. COHNR2022-12-19
G006D5060000510PRECHOPPER COMBO CROSS SECTION SHARP TIPDAUD JEE MFG. COHNR2022-12-19
G006D507000030CAPSULORRHEXIS FORCEPS 11MM ANGLEDDAUD JEE MFG. COHNR2022-12-19
G006D50800012340TITANIUM CAPSULORRHEXIS FORCEPS ERGONOMIC HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D508000123410TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 12MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123420TITANIUM CAPSULORRHEXIS FORCEPS ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123430TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17