FDA.reportPublic FDA data

Rotatable Grasping Forcep

Primary DI
00850025860635
Brand
Rotatable Grasping Forcep
Company
Micro-tech Usa
Model
QR01-ART
Device description
Rotatable Grasp Frcp Alli-Rat Tooth
Published
2025-03-04
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

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
00850025860635PackageGS15In Commercial Distribution
10850025860632PackageGS15In Commercial Distribution
00850025860628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025860635008500258606358500258606350850025860635
1085002586063210850025860632
00850025860628008500258606288500258606280850025860628

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079873914
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
008500258605055-Piece Valve KitBW01-FUJ5-F72025-03-03
00850025860697Air/Water Channel Cleaning AdapterBW01-FUJC-F72025-03-04
008500258607104-Piece Valve KitBW01-FUJ4-F72025-03-04
008500258608713-Piece Valve KitBW01-FUJ3-F72025-03-04
00858276007700Polyp Trap single chamber bulkPT50-50-S2025-09-09
10858276007707Polyp Trap single chamber bulkPT50-50-S2025-09-09
00850025860857CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
00850025860901CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
00858276007977CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
10850025860908CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
10858276007974CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
10858276007981Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
00850025860802Scope Tip ProtectorBW03-DTPS2025-03-11
00850025860819Scope Tip ProtectorBW03-DTPL2025-03-11
10850025860809Scope Tip ProtectorBW03-DTPS2025-03-11
10850025860816Scope Tip ProtectorBW03-DTPL2025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
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06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
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06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
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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
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06934415030106ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030113ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030120ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18