20GA End Irrigating Light Pipe - 297 Connector

Primary DI
10632307000192
Brand
20GA End Irrigating Light Pipe - 297 Connector
Company
PEREGRINE SURGICAL, LTD.
Model
PD102.02
Device description
20GA End Irrigating Light Pipe - 297 Connector
Published
2016-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980797000PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATORPeregrine Surgical , Ltd.1998-05-19MPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307000192PackageGS15In Commercial Distribution
00632307000195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700019210632307000192
00632307000195006323070001956323070001950632307000195

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge20Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
622467348
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1063230700229523GA Soft Tip Cannula - 1mm Silicone1272.SD123-002023-05-10
1063230700230125GA Soft Tip Cannula - 1mm Silicone1272.SD125-002023-05-10
1063230700231825GA Flexible 41GA Cannula1270.05-002023-05-10
1063230700146520GA Soft Tip CannulaPD220.002016-05-06
1063230700147220GA Flexible 41GA CannulaPD220.412016-05-06
1063230700148923GA Soft Tip CannulaPD223.002016-05-06
1063230700149623GA Soft Tip Cannula - 1mm SiliconePD223.012016-05-06
1063230700150223GA Flexible 41GA CannulaPD223.412016-05-06
1063230700151925GA Soft Tip CannulaPD225.002016-05-06
1063230700152625GA Soft Tip Cannula - 1mm SiliconePD225.012016-05-06
1063230700153325GA Flexible 41GA CannulaPD225.412016-05-06
10632307002202DMEK/DSAEK Infusion SleevePD500.272018-02-01
10632307002226DMEK Infusion SleevePD500.272018-05-15
10632307002240DMEK/DSAEK Infusion SleevePD500.272018-10-18
1063230700024623GA Light Pipe - GrieshaberPD103.232016-05-06
1063230700033823GA Straight Pick - AlconPD123.03A2016-05-06
1063230700087123GA Light Pipe - AlconPD102.232016-05-06
1063230700095620GA Light PipePD100.002016-05-06
1063230700096320GA Side Irrigating Light PipePD100.012016-05-06
1063230700097020GA End Irrigating Light PipePD100.022016-05-06

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00810123483617Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
00810123483624Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
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