FDA.reportPublic FDA data

Olympus

Primary DI
14953170401074
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FS-200L
Device description
Single Use Surgical Scissors FS-200
Published
2018-12-17
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
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170401074PackageGS11In Commercial Distribution
04953170401077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317040107414953170401074
04953170401077049531704010774953170401077

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, single-useA flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029957ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029964ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029971ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029988ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029995ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030007ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030014ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030021ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030038ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030045ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030052ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030069ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030076ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030083ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030090ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030106ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030113ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030120ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030137ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030144ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18