Monofilament, Fine

GUDID 10632307002189

Monofilament, Fine

PEREGRINE SURGICAL, LTD.

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10632307002189
NIH Device Record Key2aa3f224-7e4e-4c3c-a53b-7f5e2531466f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonofilament, Fine
Version Model NumberPD100.06
Company DUNS622467348
Company NamePEREGRINE SURGICAL, LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com
Phone215-348-0456
Emailjayne@peregrine-surgical.com

Device Dimensions

Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307002182 [Primary]
GS110632307002189 [Package]
Contains: 00632307002182
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPAEndoilluminator

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

[10632307002189]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-01-10

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10632307002318 - 25GA Flexible 41GA Cannula2023-05-18 25GA Flexible 41GA Cannula
00632307002144 - 60 Degree DMEK/DSAEK Forceps2020-08-24 60 Degree DMEK/DSAEK Forceps
10632307001465 - 20GA Soft Tip Cannula2019-10-07 20GA Soft Tip Cannula
10632307001472 - 20GA Flexible 41GA Cannula2019-10-07 20GA Flexible 41GA Cannula
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