FDA.reportPublic FDA data

Tobra Graft Compressor

Primary DI
10852360007024
Brand
Tobra Graft Compressor
Company
Tobra Medical, Inc.
Model
GC-100
Catalog number
GC-100
Device description
Tobra Graft Compressor with mesh filtration basket
Published
2023-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYZTrap, Sterile Specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYZTrap, Sterile SpecimenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852360007024PackageGS15In Commercial Distribution
00852360007027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085236000702410852360007024
00852360007027008523600070278523600070270852360007027

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgery tissue debris collector, single-useA container designed to collect bone, cartilage, or adjacent soft-tissue debris/fragments (e.g., extracted by shaving or drilling procedures) during orthopaedic surgery (e.g., autograft transplantation). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in sterile double peal pouch in dry area

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 877-1505info@tobramedical.com

Regulatory Flags#

DUNS number
082014645
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852360007027Tobra Graft CompressorGC-100GC-1002023-05-18
00852360007034Tobra FeatherFlowFF-100FF-1002023-05-18
10852360007031Tobra FeatherFlowFF-100FF-1002023-05-18
00852360007003Tobra Bone BasketBB-100BB-1002023-05-15
10852360007000Tobra Bone BasketBB-100BB-1002023-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057578286Polyp TrapsJiangsu Vedkang Medical Science and Technology Co.,Ltd.BYZ2026-05-22
00861092002613CeaLogic Specimen Collection KitRECIBIO, INC.BYZ2026-03-01
04260647240382OsteoPointMorpheus AGBYZ2024-11-26
06975238202561CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2024-07-12
10192253024449ArgyleCardinal Health 200, LLCBYZ2024-02-14
50192253024447ArgyleCardinal Health 200, LLCBYZ2024-02-14
00852360007027Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
00852360007003Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM991Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
00860006413903Bone dust trapRIM Medical Technologies IncorporatedBYZ2022-07-10
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28
04260647240122Rebellion Tissue TrapMorpheus AGBYZ2022-06-27
10885632120343MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
50885632120341MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
10885632120336MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
50885632120334MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
00840117310377Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile Dynarex CorporationBYZ2021-04-22
00840117310384Mucus Specimen TrapDYNAREX CORPORATIONBYZ2021-04-22
10080196818624MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196999231MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196818625MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196999232MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196997411MEDLINEMEDLINE INDUSTRIES, INC.BYZ2020-10-28
40080196715542MedlineMEDLINE INDUSTRIES, INC.BYZ2020-10-28