FDA.reportPublic FDA data

TREWAVIS SURGICAL

Primary DI
09340254029442
Brand
TREWAVIS SURGICAL
Company
TREWAVIS SURGICAL INSTRUMENTS PTY LTD
Model
SBT 200
Catalog number
SBT 200
Device description
MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool - Sterile Single Use - 5 Pack)
Published
2022-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09340254029442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09340254029442093402540294429340254029442

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
746296651
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09340254029534TREWAVIS SURGICAL501-001-B501-001-B2025-06-05
09340254029541TREWAVIS SURGICAL501-001-G501-001-G2025-06-05
09340254029558TREWAVIS SURGICAL501-001-S501-001-S2025-06-05
09340254000632TREWAVIS SURGICALSBT100100-010-002016-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211953Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211977Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212059Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212103Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224878Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224885Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224892Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224915Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224939Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603230817Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06975339628871Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-10-19
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027298ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027304ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027311ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027328ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027335ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027342ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027557ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027564ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027571ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027588ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027595ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027601ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027618ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027625ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30