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
00190776423612MillenniumAvalign Technologies, Inc.LRW2026-08-07
00190776423674MillenniumAvalign Technologies, Inc.LRW2026-08-07
00190776423698MillenniumAvalign Technologies, Inc.LRW2026-08-07
00190776407568MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422783MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422868MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776407476MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422493MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422608MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422202MillenniumAvalign Technologies, Inc.LRW2026-07-28
00198506092800ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093036ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093326ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093401ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
B382SD9037871020Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871030Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871090Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741050Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741100Surgical DirectSurgical Direct, Inc.LRW2026-07-28
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17
00840183531546BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531553BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531577BR Surgical, LLCBR Surgical, LLCLRW2026-07-17