FDA.reportPublic FDA data

Sharpoint

Primary DI
10848782028808
Brand
Sharpoint
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
76-5261
Catalog number
76-5261
Device description
5.2 mm Implant Knife Angled, Bevel Up
Published
2021-08-21
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
10848782028808PackageGS16In Commercial Distribution
00848782028801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202880810848782028808
00848782028801008487820288018487820288010848782028801

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782006021OnatecOB112210OB1122102022-04-26
00848782006038OnatecOB211830OB2118302022-04-26
00848782006045OnatecOB211845OB2118452022-04-26
00848782006052OnatecOB311345OB3113452022-04-26
00848782006069OnatecOB341902OB3419022022-04-26
00848782006076OnatecOB341920OB3419202022-04-26
00848782006083OnatecOB341925OB3419252022-04-26
00848782006090OnatecOB351102OB3511022022-04-26
00848782006106OnatecOB351345OB3513452022-04-26
00848782006113OnatecOB418535OB4185352022-04-26
00848782006120OnatecOB418545OB4185452022-04-26
00848782006137OnatecOB468055OB4680552022-04-26
00848782006144OnatecOB468530OB4685302022-04-26
00848782006151OnatecOB468535OB4685352022-04-26
00848782006168OnatecOB468545OB4685452022-04-26
00848782006175OnatecOB468555OB4685552022-04-26
00848782006182OnatecOB498545OB4985452022-04-26
00848782008421"C22 5-0 Grn Brd Pvn 18""/45cm"1176B11762015-10-20
00848782008438"C6 4-0 Grn Brd Pvn 18""/45cm"1180B11802015-10-20
00848782008445"C6 4-0 Wht Brd Pvn 18""/45cm"1205B12052015-10-20

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