FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647010181
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
153
Catalog number
08990
Device description
SHEARS BONE CUTTING
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRRSCISSORS, ORTHOPEDIC, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613647010181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647010181006136470101816136470101810613647010181

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
20613647010901FisherbrandSC-150-100135001002025-04-30
20613647010918FisherbrandSC-180-100135001012025-04-30
20613647010925FisherbrandSC-220-100135001022025-04-30
20613647010932FisherbrandSC-250-100135001032025-04-30
20613647018846Fisherbrand23101000231010002025-04-30
20613647018853Fisherbrand23101001231010012025-04-30
20613647018860Fisherbrand23101002231010022025-04-30
20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453049223Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2026-03-02
00810207783954Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783961Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783978Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783985Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
04059453054517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2025-08-28
00757770505784Bausch + LombBausch & Lomb IncorporatedHRR2025-08-08
00194613061821MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613096328MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114121MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114671MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114688MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613115135MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613120092MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
B35675470110American MedicalsAmerican MedicalsHRR2025-06-30
B35675475110American MedicalsAmerican MedicalsHRR2025-06-25
00194613096311MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613096342MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613115142MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00846338005634Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005641Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005658Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005665Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005672Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338002237Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338003111Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005214Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005238Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338006815Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338006822Bone CuretteELLIQUENCE, LLCHRR2025-01-09