FDA.report

Sharpoint

Primary DI
10848782024978
Brand
Sharpoint
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
J8704D
Device description
Polypropylene, 6-0, 18", RB-2, 1/2C Taperpoint 13mm
Published
2022-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848782024978PackageGS136In Commercial Distribution
00848782024971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202497810848782024978
00848782024971008487820249718487820249710848782024971

GMDN Terms

TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
10848782051516QuillVLP-4160 2025-07-11
00848782051786OnatecOL144091OL1440912025-06-02
00848782051793OnatecOL415691OL4156912025-06-02
00848782051809OnatecOL456291OL4562912025-06-02
10848782051813OnatecON456291ON4562912025-06-02
10848782051820OnatecON245071ON2450712025-06-02
10848782051837OnatecON146571ON1465712025-06-02
10848782051844OnatecON244081ON2440812025-06-02
10848782051851OnatecON454081ON4540812025-06-02
00848782051861OnatecOL145091OL1450912025-06-02
00848782051878OnatecOL415591OL4155912025-06-02
00848782051892OnatecOL145081OL1450812025-06-02
00848782051908OnatecOL415681OL4156812025-06-02
10848782051912OnatecOE261391OE2613912025-06-02
10848782051929OnatecOE471691OE4716912025-06-02
10848782051936OnatecON456671ON4566712025-06-02
10848782051943OnatecOE481691OE4816912025-06-02
10848782051950OnatecOE341331OE3413312025-06-02
00848782051960OnatecOL494891OL4948912025-06-02
00848782051977OnatecOL415592OL4155922025-06-02

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00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
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03661522101995COROLENE®PETERS SURGICALGAW2026-03-06
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03661522102107COROLENE®PETERS SURGICALGAW2026-03-06
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