FDA.report

Unique Edge

Primary DI
10840120302007
Brand
Unique Edge
Company
Unique Technologies, Inc.
Model
52-2851
Device description
2.8 mm AK Slit Knife, Angled
Published
2023-09-01
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
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840120302007PackageGS16In Commercial Distribution
00840120302000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084012030200710840120302007
00840120302000008401203020008401203020000840120302000

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags

DUNS number
927892380
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840120300310Unique Edge58-20082023-09-01
00840120300327Unique Edge58-20102023-09-01
00840120300334Unique Edge58-23122023-09-01
00840120300341Unique Edge52-18402023-09-01
00840120300365Unique Edge52-15312023-09-01
00840120300372Unique Edge52-15522023-09-01
00840120300389Unique Edge52-15512023-09-01
00840120300396Unique Edge52-15012023-09-01
00840120300402Unique Edge54-10102023-09-01
00840120300426Unique Edge52-24312023-09-01
00840120300433Unique Edge52-24422023-09-01
00840120300440Unique Edge52-24402023-09-01
00840120300457Unique Edge52-25312023-09-01
00840120300464Unique Edge52-2561-G2023-09-01
00840120300495Unique Edge52-28302023-09-01
00840120300501Unique Edge52-28482023-09-01
00840120300518Unique Edge52-28612023-09-01
00840120300525Unique Edge52-2861-G2023-09-01
00840120300532Unique Edge51-20012023-09-01
00840120300549Unique Edge51-23612023-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
00850072675008MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675015MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675053MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675060MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675077MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675084MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675121MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675152MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675169MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675190MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675220MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16