FDA.reportPublic FDA data

devemed

Primary DI
04061644005697
Brand
devemed
Company
devemed GmbH
Model
3080
Device description
Side cutter 14 cmfor soft wires up to 1.3 mmfor hard wires up to 0.6 mm
Published
2020-05-01
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
04061644005697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061644005697040616440056974061644005697

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
+4974679491990info@devemed.de

Regulatory Flags#

DUNS number
506826739
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061644037469Reicodent02-2599-00 C2020-05-04
04061644041169Reicodent02-1082020-05-04
04061644048601Reicodent02-25942020-05-04
04061644048625Reicodent02-2595-1 G2020-05-04
04061644048632Reicodent02-2595-1 S2020-05-04
04061644048649Reicodent02-2595-1 ST2020-05-04
04061644048663Reicodent02-2595-2 G2020-05-04
04061644048670Reicodent02-2595-2 S2020-05-04
04061644048731Reicodent02-2595-A2020-05-04
04061644048748Reicodent02-2595-B2020-05-04
04061644048755Reicodent02-2595-C2020-05-04
04061644048854Reicodent02-26932020-05-04
04061644048908Reicodent02-27072020-05-04
04061644048915Reicodent02-27082020-05-04
04061644048922Reicodent02-27092020-05-04
04061644048939Reicodent02-2746-12020-05-04
04061644048946Reicodent02-2746-22020-05-04
04061644048953Reicodent02-2746-32020-05-04
04061644048960Reicodent02-2746-42020-05-04
04061644048977Reicodent02-2746-52020-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
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D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15
00841435124912TecometTECOMET INC.HXZ2025-09-05
00190776409432MillenniumAvalign Technologies, Inc.HXZ2025-09-02
10818674026298Knotless flush cutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-12
10818674025994Multi Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-11
00190776407766MillenniumAvalign Technologies, Inc.HXZ2025-08-01
00194613013912MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01