FDA.reportPublic FDA data

25GA Membrane Scraper

Primary DI
00632307002281
Brand
25GA Membrane Scraper
Company
Peregrine Surgical, Llc
Model
1290.S25-00
Device description
25GA Membrane Scraper
Published
2023-05-10
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307002288PackageGS15In Commercial Distribution
00632307002281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700228810632307002288
00632307002281006323070022816323070022810632307002281

GMDN Terms#

Term, Definition table
TermDefinition
Epiretinal/inner limiting membrane scraper, single-useA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer) intended to effectively grip/lift the membrane for further manipulation (e.g., with forceps); it may additionally include non-powered features (e.g., fibreoptics) to allow cold light to be directed to the surgical site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
622467348
Device count
1
DM exempt
true
Premarket 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 DIBrandModelCatalogPublished
0063230700214460 Degree DMEK/DSAEK ForcepsPD427.602020-08-14
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

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