DMEK Infusion Sleeve

GUDID 10632307002226

DMEK Infusion Sleeve

PEREGRINE SURGICAL, LTD.

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID10632307002226
NIH Device Record Key3b31bdc3-5583-42a2-b322-731894f31b20
Commercial Distribution StatusIn Commercial Distribution
Brand NameDMEK Infusion Sleeve
Version Model NumberPD500.27
Company DUNS622467348
Company NamePEREGRINE SURGICAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com
Phone215-348-0456
Emailryan@peregrine-surgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307002229 [Primary]
GS110632307002226 [Package]
Contains: 00632307002229
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

KYGDevice, Irrigation, Ocular Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

[10632307002226]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2018-05-15

Devices Manufactured by PEREGRINE SURGICAL, LTD.

00632307002274 - 23GA Membrane Scraper2023-05-18 23GA Membrane Scraper
00632307002281 - 25GA Membrane Scraper2023-05-18 25GA Membrane Scraper
10632307002295 - 23GA Soft Tip Cannula - 1mm Silicone2023-05-18 23GA Soft Tip Cannula - 1mm Silicone
10632307002301 - 25GA Soft Tip Cannula - 1mm Silicone2023-05-18 25GA Soft Tip Cannula - 1mm Silicone
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.