FDA.reportPublic FDA data

SAFETRAP TISSUE COLLECTOR

Primary DI
00850000126107
Brand
SAFETRAP TISSUE COLLECTOR
Company
Oto-Med, Inc.
Model
SP-2000
Device description
SAFETRAP TISSUE COLLECTOR
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850000126107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000126107008500001261078500001261070850000126107

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, sterileA sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
059817742
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000126077spineX BONE DUST COLLECTORS-45002018-09-21
00850000126169CI UNIVERSAL DRAPESD-23002021-11-19
00850000126084GLASSCOCK OTOLOGY SURGERY DRAPESD-21002018-09-21
00850000126091GLASSCOCK NEUROTOLOGY SURGERY DRAPESD-22002018-09-21
10850000126166CI UNIVERSAL DRAPESD-23002021-11-19
00850000126121OTOMED® SUCTION TUBINGSP-40002018-09-21
00850000126152LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
10850000126159LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
00850000126015GLASSCOCK® EAR DRESSING, ADULTS-10002018-09-21
00850000126022GLASSCOCK® EAR DRESSING, PEDIATRICS-10032018-09-21
00850000126046SHEEHY BONE DUST COLLECTORS-25002018-09-21
00850000126060COX BONE DUST COLLECTORS-35002018-09-21
00850000126138EAR DRESSING, ADULTS-10002020-11-30
00850000126145EAR DRESSING, PEDIATRICS-10032020-11-30
10850000126135EAR DRESSING, ADULTS-10002020-11-30
10850000126142EAR DRESSING, PEDIATRICS-10032020-11-30
00850000126039HEAD & NECK PRESSURE DRESSINGS-1010-22018-09-21
00850000126114LEVINE IRRIGATION-SUCTION KITSP-30002018-09-21
00850000126053SHEEHY-HOUSE POWDER INSUFFLATORS-30012018-09-21

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
10852360007024Tobra 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