FDA.reportPublic FDA data

NA

Primary DI
16950190439214
Brand
NA
Company
Zhuji Pengtian Medical Instrument Co.,Ltd.
Model
ES-DISP-SCS
Catalog number
PTA-17046SB
Device description
Disposable Single-Action Scissors
Published
2021-04-14
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

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16950190439214PackageGS15In Commercial Distribution
06950190439217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695019043921416950190439214
06950190439217069501904392176950190439217

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

Regulatory Flags#

DUNS number
421253617
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06950190431006NAES-DISP-AGRPTG-17046EB2026-03-31
06950190431181NAES-DISP-AGR-CEPTG-17046EB2024-04-30
06950190413385NAES-DISP-BPYPTY6-17046TB2021-04-14
06950190413392NAES-DISP-BPY-CEPTY6-17046TB2021-04-14
06950190439217NAES-DISP-SCSPTA-17046SB2021-04-14
16950190413382NAES-DISP-BPYPTY6-17046TB2021-04-14
16950190413399NAES-DISP-BPY-CEPTY6-17046TB2021-04-14
16950190431003NAES-DISP-AGRPTG-17046EB2020-09-25
16950190431188NAES-DISP-AGR-CEPTG-17046EB2020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776434649MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776434793MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776433864MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436278MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436292MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776433635MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434403MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434496MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434502MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434519MillenniumAvalign Technologies, Inc.LRW2026-10-07
G141510457190Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-10-07
00190776433987MillenniumAvalign Technologies, Inc.LRW2026-10-06
00190776433994MillenniumAvalign Technologies, Inc.LRW2026-10-06
10841767100537Trinity Sterile, Inc.Trinity Sterile, Inc.LRW2026-10-06
00190776435882MillenniumAvalign Technologies, Inc.LRW2026-09-30
04059453158284Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30
04059453158307Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30
G141509455170Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G141510586170Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G1415241110Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G141560733410Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30