FDA.reportPublic FDA data

AED 21 - 1081 HD Pin Cutter, 19cm in Length

Primary DI
00848657069359
Brand
AED 21 - 1081 HD Pin Cutter, 19cm in Length
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
21-1081
Catalog number
21-1081
Device description
A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel.
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657069359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657069359008486570693598486570693590848657069359

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+8182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078535AEDAED2717B2026-10-20
00848657078542AEDAED2718B2026-10-20
00848657078559AEDAED2719B2026-10-20
00848657078481AED8815SB2026-10-08
00848657078498AED8810SB2026-10-08
00848657078504AED1010122026-10-08
00848657078511AED10121-A2026-10-08
00848657078528AEDAED26173AD2026-10-08
00848657083805AED1010162026-10-08
00848657083904AED1010012026-10-08
00848657078467AED101021-A2026-10-05
00848657078474AED101011-A2026-10-05
00848657083782AED1012112026-10-05
00848657083812AED1013112026-10-05
00848657083843AED1010662026-10-05
00848657083874AED1010002026-10-05
00848657083898AED1010212026-10-05
00848657084956AED101013T2026-10-05
00848657084963AED101066-L2026-10-05
00848657084970AED101066-S2026-10-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776061890Avalign TechnologiesAvalign Technologies, Inc.HXZ2026-10-14
00190776430979MillenniumAvalign Technologies, Inc.HXZ2026-09-18
00190776430986MillenniumAvalign Technologies, Inc.HXZ2026-09-18
00190776426569MillenniumAvalign Technologies, Inc.HXZ2026-08-19
00190776426668MillenniumAvalign Technologies, Inc.HXZ2026-08-19
00850088713299PRINCETONPrinceton Medical Group, Inc.HXZ2026-08-14
B8034606210ORTHOMEDORTHO-MED, INC.HXZ2026-07-14
B8034606250ORTHOMEDORTHO-MED, INC.HXZ2026-07-14
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
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D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
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D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15