FDA.reportPublic FDA data

Vitrectomy Infusion Sleeve - Non-Sterile

Primary DI
10632307000383
Brand
Vitrectomy Infusion Sleeve - Non-Sterile
Company
PEREGRINE SURGICAL, LTD.
Model
PD505.05
Device description
Vitrectomy Infusion Sleeve - Non-Sterile
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCANNULA, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307000383PackageGS110In Commercial Distribution
00632307000386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700038310632307000383
00632307000386006323070003866323070003860632307000386

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tissue forceps, reusableA hand-held ophthalmic surgical instrument designed to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
622467348
Device count
1
DM exempt
true
Premarket exempt
true
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
false

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
1063230700019220GA End Irrigating Light Pipe - 297 ConnectorPD102.022016-05-06
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

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Primary DI, Brand, Company table
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