FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647003767
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
TG35ML
Catalog number
0254208
Device description
TISSUE GRINDER 35ML 10/CS
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LECGRINDER, TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LECGrinder, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647003767PackageGS11In Commercial Distribution
00613647003763PrimaryGS10
10613647003760Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700376720613647003767
00613647003763006136470037636136470037630613647003763
1061364700376010613647003760

GMDN Terms#

Term, Definition table
TermDefinition
Manual bone millA manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. 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
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
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
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853778007081BMP Medical Tissue GrinderBiomedical Polymers, Inc.LEC2023-08-21
00853778007104BMP Medical Tissue Grinder (Vitrified Tip)Biomedical Polymers, Inc.LEC2023-08-21
00853778007111BMP Medical Tissue Grinder (Vitrified Tip)Biomedical Polymers, Inc.LEC2023-08-21
00853778007074BMP Medical Tissue GrinderBiomedical Polymers, Inc.LEC2023-08-21
10853778007088BMP Medical Tissue GrinderBiomedical Polymers, Inc.LEC2023-08-21
00853778007098BMP Medical Tissue GrinderBiomedical Polymers, Inc.LEC2023-08-21
10853778007101BMP Medical Tissue Grinder (Vitrified Tip)Biomedical Polymers, Inc.LEC2023-08-21
10853778007118BMP Medical Tissue Grinder (Vitrified Tip)Biomedical Polymers, Inc.LEC2023-08-21
00613647003756FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
00613647003763FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
00613647003770FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
00613647003787FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
00613647003794FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
20613647003750FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
20613647003774FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
20613647003781FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
20613647003798FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEC2022-12-07
00885380024477CARDINAL HEALTHCardinal Health 200, LLCLEC2022-11-15
50885380024472CARDINAL HEALTHCardinal Health 200, LLCLEC2022-11-15