FDA.reportPublic FDA data

Premier Edge® Microsurgical Knives

Primary DI
10845819001940
Brand
Premier Edge® Microsurgical Knives
Company
OASIS MEDICAL, INC.
Model
PE3630, B- PE3630
Device description
3.0 mm Round Tunnel Knives
Published
2023-04-30
Public version status
New
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
HNNKnife, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845819001940PackageGS16In Commercial Distribution
20845819001947PackageGS150In Commercial Distribution
00845819001943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900194010845819001940
2084581900194720845819001947
00845819001943008458190019438458190019430845819001943

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
9093055400customerservice@oasismedical.com

Regulatory Flags#

DUNS number
194121018
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
10845819005474SOFT PLUG® Extended Duration Plugs 5032023-06-30
10845819005498SOFT PLUG® Extended Duration Plugs 5052023-06-30
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
00845819003138Surgeon's Choice CardSCK-2012, B-SCK-20122025-10-02
00845819006375Surgeon's Choice CardSCK 2005, B-SCK 20052023-06-30
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
00845819002919Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
00845819002926Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
00845819002988Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002971Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
10845819002985Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002322Premier Edge® Microsurgical KnivesPE4827-TL, B-PE4827-TL2023-04-30
00845819000267SOFT PLUG® Extended Duration Plugs 6400V2023-07-31
10845819000219SOFT PLUG® Extended Duration Plugs 6402, 6402-A2023-07-31
10845819000097SOFT PLUG® Silicone Punctum Plug6610-EP2023-06-30
10845819000110SOFT PLUG® Silicone Punctum Plug6611-EP2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033802Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033819Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033826Scleral Knife Angled AKTIVE SRLHNN2024-01-17
08052276033833Stab Knife 15° AKTIVE SRLHNN2024-01-17
08052276033840Stab Knife 15° with protectionAKTIVE SRLHNN2024-01-17
08052276033857Stab Knife 22,5°AKTIVE SRLHNN2024-01-17
08052276033864Stab Knife 22,5° with protectionAKTIVE SRLHNN2024-01-17
08052276033871Stab Knife 30° AKTIVE SRLHNN2024-01-17
08052276033888Stab Knife 30° with protectionAKTIVE SRLHNN2024-01-17
08052276033895Stab Knife 45° AKTIVE SRLHNN2024-01-17
08052276033901Stab Knife 45° with protectionAKTIVE SRLHNN2024-01-17
08052276033918Blunt tip Knife 4.0 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033925Blunt tip Knife 4.0 mm Angled Bevel Up with protectionAKTIVE SRLHNN2024-01-17