FDA.reportPublic FDA data

REMOTION

Primary DI
00886385010496
Brand
REMOTION
Company
Stryker GmbH
Model
910-1003
Catalog number
910-1003
Device description
Wire and Plate Cutter
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00886385010496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385010496008863850104968863850104960886385010496

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
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
00194613013929MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013936MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013943MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013950MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613015893MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01